Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-27 @ 5:58 AM
Study NCT ID:
NCT00466167
Status:
COMPLETED
Last Update Posted:
2014-07-08
First Post:
2007-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pivotal Study in Advanced Parkinsons Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077487', 'term': 'Pramipexole'}], 'ancestors': [{'id': 'D052160', 'term': 'Benzothiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the first dose of trial medication onwards up to the end of the trial (up to 34 weeks)', 'description': 'After a 7-week double-blind flexible up-titration phase, there was an up to 26-week double-blind maintenance phase, followed by a 1-week downtitration phase (only for those patients not entering the open-label extension study).', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day\n\nMatching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning', 'otherNumAtRisk': 178, 'otherNumAffected': 74, 'seriousNumAtRisk': 178, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'Pramipexole ER', 'description': 'Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning', 'otherNumAtRisk': 164, 'otherNumAffected': 73, 'seriousNumAtRisk': 164, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': 'Pramipexole IR', 'description': 'Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"', 'otherNumAtRisk': 175, 'otherNumAffected': 90, 'seriousNumAtRisk': 175, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 34}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 30}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}], 'seriousEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Post viral fatigue syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Hallucination, visual', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Delusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'On and off phenomenon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Radiculpathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Renal failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Uterine prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Forearm fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Ligament injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Peripheral nerve injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Tendon injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}, {'term': 'Medical device change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 175, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 11.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Score at Week 18", 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pramipexole ER', 'description': 'Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}, {'id': 'OG001', 'title': 'Pramipexole IR', 'description': 'Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day\n\nMatching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.0', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-12.8', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '-6.1', 'spread': '0.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference from placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.9', 'ciLowerLimit': '2.4', 'ciUpperLimit': '7.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.3', 'groupDescription': 'ANCOVA with factors treatment, pooled country and covariate baseline', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted mean difference from placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.6', 'ciLowerLimit': '4.2', 'ciUpperLimit': '9.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.2', 'groupDescription': 'ANCOVA with factors treatment, pooled country and covariate baseline', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and week 18', 'description': 'UPDRS II+III total score on Full Analysis Set (FAS)with LOCF (Last observation carried forward), week 18 - baseline, UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms', 'unitOfMeasure': 'Percentage of change from baseline', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS 1) population = 507 patients FAS 1 defined as all patients who were dispensed study medication, were documented to have at least one dose of study medication, were treated for 18 weeks (or had prematurely discontinued treatment prior to week 18) and provided baseline and any on-drug post-baseline efficacy assessment'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percentage Off-time at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pramipexole ER', 'description': 'Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}, {'id': 'OG001', 'title': 'Pramipexole IR', 'description': 'Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day\n\nMatching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.3', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-15.9', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '-8.8', 'spread': '1.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0122', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted mean difference from Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.5', 'ciLowerLimit': '1.0', 'ciUpperLimit': '7.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.8', 'groupDescription': 'ANCOVA with factors treatment, pooled country and covariate baseline', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted mean difference from placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.1', 'ciLowerLimit': '3.7', 'ciUpperLimit': '10.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.7', 'groupDescription': 'ANCOVA with factors treatment, pooled country and covariate baseline', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and week 18', 'description': 'Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).', 'unitOfMeasure': 'Percentage of off-time', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS 1) population with last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percentage On-time Without Dyskinesia at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pramipexole ER', 'description': 'Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}, {'id': 'OG001', 'title': 'Pramipexole IR', 'description': 'Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day\n\nMatching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}], 'classes': [{'categories': [{'measurements': [{'value': '11.9', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '12.6', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '8.9', 'spread': '1.6', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and week 18', 'description': 'Percentage on-time based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.', 'unitOfMeasure': 'Percentage of on-time without dyskinesia', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS 1) population with last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pramipexole ER', 'description': 'Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}, {'id': 'OG001', 'title': 'Pramipexole IR', 'description': 'Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day\n\nMatching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '1.2', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and week 18', 'description': 'Percentage on-time with non-troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.', 'unitOfMeasure': 'Percentage of on-time', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS 1) population with last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percentage On-time With Troublesome Dyskinesia at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pramipexole ER', 'description': 'Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}, {'id': 'OG001', 'title': 'Pramipexole IR', 'description': 'Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day\n\nMatching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '0.5', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and week 18', 'description': 'Percentage on-time with troublesome dyskinesia based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.', 'unitOfMeasure': 'Percentage of on-time', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS 1) population with last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression - Global Improvement (CGI-I) Responder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}, {'value': '171', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pramipexole ER', 'description': 'Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}, {'id': 'OG001', 'title': 'Pramipexole IR', 'description': 'Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day\n\nMatching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}], 'classes': [{'title': 'Responder', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}]}, {'title': 'Non-Responder', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'after 18 weeks of treatment', 'description': "CGI-I scores ranging from '1' (very much improved) to '7' (very much worse), CGI-I responder have scoring of 1 or 2 (at least much improved)", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS 1) population with last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Response in Patient Global Impression (PGI-I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pramipexole ER', 'description': 'Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}, {'id': 'OG001', 'title': 'Pramipexole IR', 'description': 'Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day\n\nMatching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}], 'classes': [{'title': 'Responder', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}]}, {'title': 'Non-Responder', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'after 18 weeks of treatment', 'description': "PGI-I scores ranging from '1' (very much better) to '7' (very much worse), PGI-I responder have scoring 1 or 2 (at least much better)", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS 1) population with last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in UPDRS I Score After 18 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pramipexole ER', 'description': 'Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}, {'id': 'OG001', 'title': 'Pramipexole IR', 'description': 'Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day\n\nMatching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '0.0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-1.0', 'upperLimit': '0.0'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '-1.0', 'upperLimit': '0.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline and 18 weeks', 'description': 'UPDRS I ranging from 0 (normal) to 16 (severe). UPDRS I measures Mentation, Behavior and Mood', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS 1) population with last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in UPDRS II Score After 18 Weeks, Average at on and Off-period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pramipexole ER', 'description': 'Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}, {'id': 'OG001', 'title': 'Pramipexole IR', 'description': 'Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day\n\nMatching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.7', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '0.3', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and 18 weeks', 'description': 'UPDRS II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS part II at on and UPDRS part II at off-period for each of the 13 activities.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS 1) population with last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in UPDRS III Score After 18 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pramipexole ER', 'description': 'Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}, {'id': 'OG001', 'title': 'Pramipexole IR', 'description': 'Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day\n\nMatching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.3', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-9.2', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '-4.3', 'spread': '0.7', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and 18 weeks', 'description': 'UPDRS III ranging from 0 (normal) to 108 (severe). UPDRS part III measures motor symptoms', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS 1) population with last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in UPDRS IV Score After 18 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pramipexole ER', 'description': 'Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}, {'id': 'OG001', 'title': 'Pramipexole IR', 'description': 'Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day\n\nMatching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '0.2', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and 18 weeks', 'description': 'UPDRS IV ranging from 0 (normal) to 23 (severe). UPDRS IV measures complications of therapy', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS 1) population with last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Beck's Depression Inventory (BDI) After 18 Weeks", 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}, {'value': '171', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pramipexole ER', 'description': 'Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}, {'id': 'OG001', 'title': 'Pramipexole IR', 'description': 'Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day\n\nMatching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.2', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '-4.0', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '-2.8', 'spread': '0.5', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and 18 weeks', 'description': 'ranging from 0 (best case) to 63 (worst case)', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS 1) population with last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Parkinson's Disease Sleep Scale (PDSS) After 18 Weeks", 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}, {'value': '171', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pramipexole ER', 'description': 'Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}, {'id': 'OG001', 'title': 'Pramipexole IR', 'description': 'Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day\n\nMatching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}], 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '4.9', 'spread': '1.7', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and 18 weeks', 'description': 'ranging from 0 (worst case) to 150 (best case)', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS 1) population with last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Parkinson's Disease Quality of Life Questionnaire 39 After 18 Weeks", 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pramipexole ER', 'description': 'Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}, {'id': 'OG001', 'title': 'Pramipexole IR', 'description': 'Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day\n\nMatching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.1', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '-13.1', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '-6.2', 'spread': '1.8', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and 18 weeks', 'description': 'Ranging from 0 (best case) to 156 (worst case)', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS 1) population with last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in European Quality of Life (EuroQol) Scale After 18 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pramipexole ER', 'description': 'Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}, {'id': 'OG001', 'title': 'Pramipexole IR', 'description': 'Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day\n\nMatching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '7.6', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '1.3', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and 18 weeks', 'description': 'ranging from 0 (worst case) to 100 (best case)', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS 1) population with last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 11-point Likert Scale for Pain Related to PD at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}, {'value': '171', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pramipexole ER', 'description': 'Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}, {'id': 'OG001', 'title': 'Pramipexole IR', 'description': 'Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day\n\nMatching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '0.2', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and week 18', 'description': 'Likert scale is a method used for the measurement of pain. The patients were asked to rate their pain related to PD by ticking the number that best described their pain on the average in the previous week, from zero for "no pain" to ten for "unbearable pain".', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS 1) population with last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Clinically Significant Abnormalities: Clinical Laboratory Evaluations (Biochemistry and Haematology)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '158', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pramipexole ER', 'description': 'Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}, {'id': 'OG001', 'title': 'Pramipexole IR', 'description': 'Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day\n\nMatching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}], 'classes': [{'title': 'Haematocrit - decrease', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '26.8', 'upperLimit': '43.5'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '32.4', 'upperLimit': '48.8'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '13.5', 'upperLimit': '26.9'}]}]}, {'title': 'Haemoglobin - decrease', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Red blood cell ct - decrease', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Eosinophils - Increase', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Neut.,poly. (segs),absol. - decrease', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Sodium - decrease', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'GGT - increase', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Glucose - decrease', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Glucose - increase', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Triglyceride - increase', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Weight - decrease', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Blood pressure - increase', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Blood pressure - decrease', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline and week 18', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (TS 1) population: defined as all patients who were dispensed study medication, were documented to have at least one dose of study medication and were treated for 18 weeks (or had discontinued treatment prior to week 18). Data limited to visit 8 (or V11 in case of premature discontinuation before visit 8).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pramipexole ER', 'description': 'Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}, {'id': 'FG001', 'title': 'Pramipexole IR', 'description': 'Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day\n\nMatching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '165'}, {'groupId': 'FG001', 'numSubjects': '175'}, {'groupId': 'FG002', 'numSubjects': '178'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '145'}, {'groupId': 'FG001', 'numSubjects': '163'}, {'groupId': 'FG002', 'numSubjects': '157'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'patient did not meet inclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}, {'value': '517', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Pramipexole ER', 'description': 'Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}, {'id': 'BG001', 'title': 'Pramipexole IR', 'description': 'Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day\n\nMatching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.6', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '62.0', 'spread': '10.3', 'groupId': 'BG001'}, {'value': '60.9', 'spread': '9.7', 'groupId': 'BG002'}, {'value': '61.5', 'spread': '9.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '233', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}, {'value': '284', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 517}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'lastUpdateSubmitDate': '2014-06-24', 'studyFirstSubmitDate': '2007-04-25', 'resultsFirstSubmitDate': '2009-11-17', 'studyFirstSubmitQcDate': '2007-04-25', 'lastUpdatePostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-01-19', 'studyFirstPostDateStruct': {'date': '2007-04-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Score at Week 18", 'timeFrame': 'baseline and week 18', 'description': 'UPDRS II+III total score on Full Analysis Set (FAS)with LOCF (Last observation carried forward), week 18 - baseline, UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Percentage Off-time at Week 18', 'timeFrame': 'baseline and week 18', 'description': 'Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease).'}, {'measure': 'Change From Baseline in Percentage On-time Without Dyskinesia at Week 18', 'timeFrame': 'baseline and week 18', 'description': 'Percentage on-time based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.'}, {'measure': 'Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia at Week 18', 'timeFrame': 'baseline and week 18', 'description': 'Percentage on-time with non-troublesome dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.'}, {'measure': 'Change From Baseline in Percentage On-time With Troublesome Dyskinesia at Week 18', 'timeFrame': 'baseline and week 18', 'description': 'Percentage on-time with troublesome dyskinesia based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period when the patient has no symptoms of off-time and is not asleep.'}, {'measure': 'Clinical Global Impression - Global Improvement (CGI-I) Responder', 'timeFrame': 'after 18 weeks of treatment', 'description': "CGI-I scores ranging from '1' (very much improved) to '7' (very much worse), CGI-I responder have scoring of 1 or 2 (at least much improved)"}, {'measure': 'Response in Patient Global Impression (PGI-I)', 'timeFrame': 'after 18 weeks of treatment', 'description': "PGI-I scores ranging from '1' (very much better) to '7' (very much worse), PGI-I responder have scoring 1 or 2 (at least much better)"}, {'measure': 'Change From Baseline in UPDRS I Score After 18 Weeks', 'timeFrame': 'baseline and 18 weeks', 'description': 'UPDRS I ranging from 0 (normal) to 16 (severe). UPDRS I measures Mentation, Behavior and Mood'}, {'measure': 'Change From Baseline in UPDRS II Score After 18 Weeks, Average at on and Off-period', 'timeFrame': 'baseline and 18 weeks', 'description': 'UPDRS II ranging from 0 (normal) to 52 (severe). UPDRS Part II is calculated as the average of UPDRS part II at on and UPDRS part II at off-period for each of the 13 activities.'}, {'measure': 'Change From Baseline in UPDRS III Score After 18 Weeks', 'timeFrame': 'baseline and 18 weeks', 'description': 'UPDRS III ranging from 0 (normal) to 108 (severe). UPDRS part III measures motor symptoms'}, {'measure': 'Change From Baseline in UPDRS IV Score After 18 Weeks', 'timeFrame': 'baseline and 18 weeks', 'description': 'UPDRS IV ranging from 0 (normal) to 23 (severe). UPDRS IV measures complications of therapy'}, {'measure': "Change From Baseline in Beck's Depression Inventory (BDI) After 18 Weeks", 'timeFrame': 'baseline and 18 weeks', 'description': 'ranging from 0 (best case) to 63 (worst case)'}, {'measure': "Change From Baseline in Parkinson's Disease Sleep Scale (PDSS) After 18 Weeks", 'timeFrame': 'baseline and 18 weeks', 'description': 'ranging from 0 (worst case) to 150 (best case)'}, {'measure': "Change From Baseline in Parkinson's Disease Quality of Life Questionnaire 39 After 18 Weeks", 'timeFrame': 'baseline and 18 weeks', 'description': 'Ranging from 0 (best case) to 156 (worst case)'}, {'measure': 'Change From Baseline in European Quality of Life (EuroQol) Scale After 18 Weeks', 'timeFrame': 'baseline and 18 weeks', 'description': 'ranging from 0 (worst case) to 100 (best case)'}, {'measure': 'Change From Baseline in 11-point Likert Scale for Pain Related to PD at Week 18', 'timeFrame': 'baseline and week 18', 'description': 'Likert scale is a method used for the measurement of pain. The patients were asked to rate their pain related to PD by ticking the number that best described their pain on the average in the previous week, from zero for "no pain" to ten for "unbearable pain".'}, {'measure': 'Clinically Significant Abnormalities: Clinical Laboratory Evaluations (Biochemistry and Haematology)', 'timeFrame': 'baseline and week 18'}]}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': 'The general aim of this trial is to determine the efficacy (as measured by the change from baseline to the end of the maintenance phase in the total score for Unified Parkinsons Disease Rating Scale Parts II and III combined), safety, and tolerability of pramipexole ER, in daily doses from 0.375 milligram to 4.5 milligram once a day, in comparison to placebo, in Levodopa combined with a Dopa-Decarboxylase-inhibitor treated Parkinson patients with advanced Parkinsons Disease and motor fluctuations.\n\nIn addition, a numerical comparison of the efficacy of pramipexole extended release versus pramipexole immediate release will be done.\n\nThe efficacy of pramipexole immediate release will also be compared to placebo, for assay sensitivity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '32 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female patient with advanced idiopathic Parkinsons disease confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity.\n2. Parkinsons disease diagnosed for at least 2 years.\n3. Patients 30 years of age or older at the time of diagnosis.\n4. Modified Hoehn and Yahr stage of 2 to 4 at on-time.\n5. Treatment with standard or controlled release Levodopa combined with a Dopa-Decarboxylase-inhibitor, or with Levodopa combined with a Dopa-Decarboxylase-inhibitor/entacapone, at an optimised dose according to investigators judgement, this dose being stable for at least 4 weeks prior to baseline visit.\n6. Motor fluctuations, with at least 2 cumulative hours of off-time every day during waking hours (documented on a patient diary completed for 2 consecutive days before baseline visit).\n7. Patient willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. In particular, after training, it has to be documented at baseline visit that the patient is able to recognise the off-time and on-time periods during waking hours and that the patient (or a family member or a guardian) is able to record them accurately in the patient diary.\n8. Signed informed consent obtained before any study procedures are carried out (in accordance with International Conference on Harmonisation-Good Clinical Practice guidelines and local legislation).\n\nExclusion Criteria:\n\n1. Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases\n2. Dementia, as defined by a Mini-Mental State Exam score \\< 24 at screening visit\n3. Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders 4th edition criteria that could prevent compliance or completion of the study and/or put the patient at risk if he/she takes part in the study\n4. History of psychosis, except history of drug induced hallucinations\n5. History of deep brain stimulation\n6. Clinically significant Electrocardiogram abnormalities at screening visit\n7. Clinically significant hypotension and/or symptomatic orthostatic hypotension at screening or baseline visit\n8. Malignant melanoma or history of previously treated malignant melanoma\n9. Any other clinically significant disease, whether treated or not, that could put the patient at risk or could prevent compliance or completion of the study\n10. Pregnancy or breast-feeding\n11. Sexually active female of childbearing potential not using a medically approved method of birth control for at least one month prior to the screening visit and throughout the study period\n12. Serum levels of Aspartate Aminotransferase (Serum Glutamic-Oxaloacetic Transaminase), Alanine Aminotransferase (Serum Glutamic Pyruvic Transaminase), alkaline phosphatases or bilirubin \\> 2 Upper Limit of Normal\n13. Patients with a creatinine clearance \\< 50 millilitres/minute\n14. Any dopamine agonist (including pramipexole) within 4 weeks prior to baseline visit\n15. Any medication with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit\n16. Any of the following drugs within 4 weeks prior to baseline visit: methylphenidate, cinnarizine, amphetamines\n17. Flunarizine within 3 months prior to baseline visit\n18. Known hypersensitivity to pramipexole or its excipients\n19. Drug abuse according to investigators judgement, within 2 years prior to screening\n20. Participation in other investigational drug studies, or use of other investigational drugs within one month or five times the half-life of the investigational drug (whichever is longer) prior to baseline visit'}, 'identificationModule': {'nctId': 'NCT00466167', 'briefTitle': 'Pivotal Study in Advanced Parkinsons Disease Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release (ER) Versus Placebo and Versus Pramipexole Immediate Release (IR) Administered Orally Over a 26-week Maintenance Phase in L-Dopa+ Treated Patients With Advanced Parkinsons Disease (PD).', 'orgStudyIdInfo': {'id': '248.525'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Pramipexole ER', 'interventionNames': ['Drug: Pramipexol Extended Release']}, {'type': 'OTHER', 'label': 'Pramipexole IR', 'interventionNames': ['Drug: Pramipexol Immediate Release']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Pramipexol Extended Release', 'type': 'DRUG', 'armGroupLabels': ['Pramipexole ER']}, {'name': 'Pramipexol Immediate Release', 'type': 'DRUG', 'armGroupLabels': ['Pramipexole IR']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Linz', 'country': 'Austria', 'facility': '248.525.43005 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'city': 'Pardubice', 'country': 'Czechia', 'facility': '248.525.42003 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.04075, 'lon': 15.77659}}, {'city': 'Prague', 'country': 'Czechia', 'facility': '248.525.42001 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Rakovník', 'country': 'Czechia', 'facility': '248.525.42005 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.1037, 'lon': 13.7334}}, {'city': 'Rychnov nad Kněžnou', 'country': 'Czechia', 'facility': '248.525.42002 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.16284, 'lon': 16.27488}}, {'city': 'Valašské Meziříčí', 'country': 'Czechia', 'facility': '248.525.42004 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 49.47181, 'lon': 17.97113}}, {'city': 'Győr', 'country': 'Hungary', 'facility': '248.525.36005 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 47.68333, 'lon': 17.63512}}, {'city': 'Kecskemét', 'country': 'Hungary', 'facility': '248.525.36003 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 46.90618, 'lon': 19.69128}}, {'city': 'Szeged', 'country': 'Hungary', 'facility': '248.525.36006 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'city': 'Veszprém', 'country': 'Hungary', 'facility': '248.525.36004 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 47.09327, 'lon': 17.91149}}, {'city': 'Bangalore', 'country': 'India', 'facility': '248.525.91004 National Institute of Mental Health & Neuro Sciences', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'city': 'Chennai', 'country': 'India', 'facility': '248.525.91002 Apollo Hospital', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'city': 'Delhi', 'country': 'India', 'facility': '248.525.91001 Institute of Human Behaviour & Allied Sciences', 'geoPoint': {'lat': 28.65195, 'lon': 77.23149}}, {'city': 'Hyderabad', 'country': 'India', 'facility': "248.525.91003 Nizam's Institute of Medical Sciences", 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'city': 'Indore', 'country': 'India', 'facility': '248.525.91007 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 22.71792, 'lon': 75.8333}}, {'city': 'Karnataka', 'country': 'India', 'facility': '248.525.91005 Mallikatta 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