Viewing Study NCT00296192

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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 3:35 PM

Ignite Modification Date: 2026-04-08 @ 2:56 PM

Study NCT ID: NCT00296192

Status: COMPLETED

Last Update Posted: 2014-10-02

First Post: 2006-02-22

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of Parkinson Symptoms

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, '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': 'C047508', 'term': 'rotigotine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+1 877 822 9493', 'title': 'UCB Clinical Trial Call Center', 'organization': 'UCB Pharma'}, 'certainAgreement': {'otherDetails': 'UCB has \\> 60 days but \\<= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Safety analyses are based on actual treatment received; 4 subjects randomized to placebo were mistreated (1 subject each in the rotigotine 1 puff, rotigotine 2 puffs, rotigotine 3 puffs, and rotigotine 4 puffs treatment arms).', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo 1-4 Puffs', 'description': 'Placebo nasal spray 1 - 4 puffs', 'otherNumAtRisk': 13, 'otherNumAffected': 3, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Rotigotine 1 Puff', 'description': 'Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)', 'otherNumAtRisk': 17, 'otherNumAffected': 9, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Rotigotine 2 Puffs', 'description': 'Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)', 'otherNumAtRisk': 17, 'otherNumAffected': 5, 'seriousNumAtRisk': 17, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Rotigotine 3 Puffs', 'description': 'Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)', 'otherNumAtRisk': 18, 'otherNumAffected': 9, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Rotigotine 4 Puffs', 'description': 'Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)', 'otherNumAtRisk': 17, 'otherNumAffected': 9, 'seriousNumAtRisk': 17, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Salivary hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Application site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Application site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Application site dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Application site paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Difficulty in walking', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Blood urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'White blood cells urine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'White blood cells urine postitive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Balance disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Dystonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Hypokinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Sleep attacks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Yawning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pallor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}], 'seriousEvents': [{'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects Who Complete the Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo 1-4 Puffs', 'description': 'Placebo nasal spray 1 - 4 puffs'}, {'id': 'OG001', 'title': 'Rotigotine 1 Puff', 'description': 'Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)'}, {'id': 'OG002', 'title': 'Rotigotine 2 Puffs', 'description': 'Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)'}, {'id': 'OG003', 'title': 'Rotigotine 3 Puffs', 'description': 'Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)'}, {'id': 'OG004', 'title': 'Rotigotine 4 Puffs', 'description': 'Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 days', 'unitOfMeasure': 'participants', 'populationDescription': 'Full Analysis Set: Subjects receiving at least one delivery of trial medication and with at least one post-baseline efficacy measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at 24 Minutes Post-dose in Unified Parkinson Disease Rating Scale (UPDRS) Part III Motor Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo 1-4 Puffs', 'description': 'Placebo nasal spray 1 - 4 puffs'}, {'id': 'OG001', 'title': 'Rotigotine 1 Puff', 'description': 'Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)'}, {'id': 'OG002', 'title': 'Rotigotine 2 Puffs', 'description': 'Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)'}, {'id': 'OG003', 'title': 'Rotigotine 3 Puffs', 'description': 'Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)'}, {'id': 'OG004', 'title': 'Rotigotine 4 Puffs', 'description': 'Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '35.1', 'spread': '7.77', 'groupId': 'OG000'}, {'value': '37.2', 'spread': '10.68', 'groupId': 'OG001'}, {'value': '39.5', 'spread': '12.94', 'groupId': 'OG002'}, {'value': '36.2', 'spread': '7.60', 'groupId': 'OG003'}, {'value': '37.6', 'spread': '9.30', 'groupId': 'OG004'}]}]}, {'title': '24 minutes post-dose', 'categories': [{'measurements': [{'value': '25.3', 'spread': '12.44', 'groupId': 'OG000'}, {'value': '30.0', 'spread': '11.35', 'groupId': 'OG001'}, {'value': '29.2', 'spread': '13.53', 'groupId': 'OG002'}, {'value': '29.1', 'spread': '8.51', 'groupId': 'OG003'}, {'value': '26.4', 'spread': '12.95', 'groupId': 'OG004'}]}]}, {'title': 'Change from baseline to 24 minutes post-dose', 'categories': [{'measurements': [{'value': '-9.8', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '-7.2', 'spread': '10.32', 'groupId': 'OG001'}, {'value': '-10.3', 'spread': '6.17', 'groupId': 'OG002'}, {'value': '-7.1', 'spread': '6.47', 'groupId': 'OG003'}, {'value': '-11.6', 'spread': '10.65', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '2.9', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '8.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.91', 'groupDescription': 'Analysis of covariance modeling change from baseline at 24 minutes post-dose in UPDRS Part III, controlling for treatment group and baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-5.7', 'ciUpperLimit': '6.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.93', 'groupDescription': 'Analysis of covariance modeling change from baseline at 24 minutes post-dose in UPDRS Part III, controlling for treatment group and baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '2.9', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '8.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.86', 'groupDescription': 'Analysis of covariance modeling change from baseline at 24 minutes post-dose in UPDRS Part III, controlling for treatment group and baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-7.4', 'ciUpperLimit': '4.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.02', 'groupDescription': 'Analysis of covariance modeling change from baseline at 24 minutes post-dose in UPDRS Part III, controlling for treatment group and baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and 24 minutes post-dose', 'description': "The Unified Parkinson's Disease Rating Scale (UPDRS) is a scale for the assessment of function in Parkinson's disease. UPDRS Part III measures Motor Examination. Range: 0 (Best score possible) to 56 (Worst score possible) Change = 24 minute value minus baseline value.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Full Analysis Set: Subjects receiving at least one delivery of trial medication and with at least one post-baseline efficacy measurement. Missing values at 24 minutes post-dose timepoint were not imputed; number of observations at 24 minutes post-dose timepoint may be less than that for baseline timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 34 Minutes Post-dose in Tapping Rate (Taps/Min)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo 1-4 Puffs', 'description': 'Placebo nasal spray 1 - 4 puffs'}, {'id': 'OG001', 'title': 'Rotigotine 1 Puff', 'description': 'Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)'}, {'id': 'OG002', 'title': 'Rotigotine 2 Puffs', 'description': 'Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)'}, {'id': 'OG003', 'title': 'Rotigotine 3 Puffs', 'description': 'Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)'}, {'id': 'OG004', 'title': 'Rotigotine 4 Puffs', 'description': 'Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '112.7', 'spread': '47.08', 'groupId': 'OG000'}, {'value': '109.8', 'spread': '28.94', 'groupId': 'OG001'}, {'value': '127.2', 'spread': '44.33', 'groupId': 'OG002'}, {'value': '115.9', 'spread': '41.05', 'groupId': 'OG003'}, {'value': '118.3', 'spread': '40.41', 'groupId': 'OG004'}]}]}, {'title': '34 minutes post-dose', 'categories': [{'measurements': [{'value': '141.2', 'spread': '50.92', 'groupId': 'OG000'}, {'value': '131.0', 'spread': '30.01', 'groupId': 'OG001'}, {'value': '138.7', 'spread': '44.42', 'groupId': 'OG002'}, {'value': '142.9', 'spread': '51.20', 'groupId': 'OG003'}, {'value': '144.4', 'spread': '57.64', 'groupId': 'OG004'}]}]}, {'title': 'Change from baseline to 34 minutes post-dose', 'categories': [{'measurements': [{'value': '28.5', 'spread': '27.83', 'groupId': 'OG000'}, {'value': '21.2', 'spread': '26.69', 'groupId': 'OG001'}, {'value': '11.5', 'spread': '11.27', 'groupId': 'OG002'}, {'value': '27.1', 'spread': '25.25', 'groupId': 'OG003'}, {'value': '22.9', 'spread': '27.75', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-8.6', 'ciLowerLimit': '-25.7', 'ciUpperLimit': '8.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.58', 'groupDescription': 'Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-16.8', 'ciLowerLimit': '-34.0', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.63', 'groupDescription': 'Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-18.2', 'ciUpperLimit': '15.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.45', 'groupDescription': 'Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-5.5', 'ciLowerLimit': '-23.3', 'ciUpperLimit': '12.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.90', 'groupDescription': 'Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 34 minutes post-dose', 'description': 'One-minute tapping rate will be calculated as the number of times a subject could tap on two 4 x 4 cm marks placed on a board 30 cm apart during 1 minute (30 cm measured from the inner border of the two boxes).', 'unitOfMeasure': 'taps per minute', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Full Analysis Set: Subjects receiving at least one delivery of trial medication and with at least one post-baseline efficacy measurement. Missing values at 34 minutes post-dose timepoint were not imputed; number of observations at 34 minutes post-dose timepoint may be less than that for baseline timepoint.'}, {'type': 'SECONDARY', 'title': '"Success Rate" (Percentage of Subjects Achieving "Off" Reversals)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo 1-4 Puffs', 'description': 'Placebo nasal spray 1 - 4 puffs'}, {'id': 'OG001', 'title': 'Rotigotine 1 Puff', 'description': 'Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)'}, {'id': 'OG002', 'title': 'Rotigotine 2 Puffs', 'description': 'Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)'}, {'id': 'OG003', 'title': 'Rotigotine 3 Puffs', 'description': 'Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)'}, {'id': 'OG004', 'title': 'Rotigotine 4 Puffs', 'description': 'Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)'}], 'classes': [{'title': 'Reversed from "off" to "on" (success)', 'categories': [{'measurements': [{'value': '70.6', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '75.0', 'groupId': 'OG002'}, {'value': '70.6', 'groupId': 'OG003'}, {'value': '75.0', 'groupId': 'OG004'}]}]}, {'title': 'Did not reverse from "off" to "on"', 'categories': [{'measurements': [{'value': '29.4', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}, {'value': '29.4', 'groupId': 'OG003'}, {'value': '25.0', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciPctValue': '95', 'paramValue': '-20.6', 'ciLowerLimit': '-53.3', 'ciUpperLimit': '12.1', 'groupDescription': '95% confidence interval in difference in success rate', 'statisticalMethod': 'Confidence interval', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportions', 'ciPctValue': '95', 'paramValue': '4.4', 'ciLowerLimit': '-25.9', 'ciUpperLimit': '34.7', 'groupDescription': '95% confidence interval in difference in success rate', 'statisticalMethod': '95% confidence interval', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportions', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-30.6', 'ciUpperLimit': '30.6', 'groupDescription': '95% confidence interval in difference in success rate', 'statisticalMethod': '95% confidence interval', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in proportions', 'ciPctValue': '95', 'paramValue': '4.4', 'ciLowerLimit': '-25.9', 'ciUpperLimit': '34.7', 'groupDescription': '95% confidence interval in difference in success rate', 'statisticalMethod': '95% confidence interval', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 hours post-dose', 'description': 'Subjects reversing from "off" to "on" following initiation of treatment. "On" and "off" state refer to periods where Parkinson\'s disease symptoms are not present ("on") and periods where symptoms are present ("off"); the "on"/"off" determination at each assessment timepoint was made by the investigator.', 'unitOfMeasure': 'percentage of participants', 'populationDescription': 'Full Analysis Set: Subjects receiving at least one delivery of trial medication and with at least one post-baseline efficacy measurement.'}, {'type': 'SECONDARY', 'title': 'Time of First "Off" Reversal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo 1-4 Puffs', 'description': 'Placebo nasal spray 1 - 4 puffs'}, {'id': 'OG001', 'title': 'Rotigotine 1 Puff', 'description': 'Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)'}, {'id': 'OG002', 'title': 'Rotigotine 2 Puffs', 'description': 'Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)'}, {'id': 'OG003', 'title': 'Rotigotine 3 Puffs', 'description': 'Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)'}, {'id': 'OG004', 'title': 'Rotigotine 4 Puffs', 'description': 'Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '65'}, {'value': '60', 'groupId': 'OG001', 'lowerLimit': '40', 'upperLimit': '60'}, {'value': '51', 'groupId': 'OG002', 'lowerLimit': '22', 'upperLimit': '84'}, {'value': '50', 'groupId': 'OG003', 'lowerLimit': '35', 'upperLimit': '70'}, {'value': '59', 'groupId': 'OG004', 'lowerLimit': '35', 'upperLimit': '190'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 6 hours post-dose', 'description': 'Number of minutes to first reversal of symptoms from "off" to "on". Estimated via Kaplan-Meier estimation method. "On" and "off" state refer to periods where Parkinson\'s disease symptoms are not present ("on") and periods where symptoms are present ("off"); the "on"/"off" determination at each assessment timepoint was made by the investigator.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'populationDescription': 'Full Analysis Set: Subjects receiving at least one delivery of trial medication and with at least one post-baseline efficacy measurement.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo 1-4 Puffs', 'description': 'Placebo nasal spray 1 - 4 puffs'}, {'id': 'FG001', 'title': 'Rotigotine 1 Puff', 'description': 'Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)'}, {'id': 'FG002', 'title': 'Rotigotine 2 Puffs', 'description': 'Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)'}, {'id': 'FG003', 'title': 'Rotigotine 3 Puffs', 'description': 'Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)'}, {'id': 'FG004', 'title': 'Rotigotine 4 Puffs', 'description': 'Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Participants flow shows all subjects randomized. Safety analyses are based on actual treatment received; 4 subjects randomized to placebo were mistreated (1 subject each in the rotigotine 1 puff, rotigotine 2 puffs, rotigotine 3 puffs, and rotigotine 4 puffs treatment arms).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '82', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo 1-4 Puffs', 'description': 'Placebo nasal spray 1 - 4 puffs'}, {'id': 'BG001', 'title': 'Rotigotine 1 Puff', 'description': 'Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)'}, {'id': 'BG002', 'title': 'Rotigotine 2 Puffs', 'description': 'Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)'}, {'id': 'BG003', 'title': 'Rotigotine 3 Puffs', 'description': 'Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)'}, {'id': 'BG004', 'title': 'Rotigotine 4 Puffs', 'description': 'Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '41', 'groupId': 'BG005'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '41', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.9', 'spread': '6.94', 'groupId': 'BG000'}, {'value': '67.1', 'spread': '7.54', 'groupId': 'BG001'}, {'value': '66.8', 'spread': '9.67', 'groupId': 'BG002'}, {'value': '63.9', 'spread': '8.28', 'groupId': 'BG003'}, {'value': '60.5', 'spread': '8.04', 'groupId': 'BG004'}, {'value': '64.4', 'spread': '8.28', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '58', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '58', 'groupId': 'BG005'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-24', 'studyFirstSubmitDate': '2006-02-22', 'resultsFirstSubmitDate': '2009-07-30', 'studyFirstSubmitQcDate': '2006-02-22', 'lastUpdatePostDateStruct': {'date': '2014-10-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-01-05', 'studyFirstPostDateStruct': {'date': '2006-02-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects Who Complete the Trial', 'timeFrame': '15 days'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline at 24 Minutes Post-dose in Unified Parkinson Disease Rating Scale (UPDRS) Part III Motor Examination', 'timeFrame': 'Baseline, and 24 minutes post-dose', 'description': "The Unified Parkinson's Disease Rating Scale (UPDRS) is a scale for the assessment of function in Parkinson's disease. UPDRS Part III measures Motor Examination. Range: 0 (Best score possible) to 56 (Worst score possible) Change = 24 minute value minus baseline value."}, {'measure': 'Change From Baseline to 34 Minutes Post-dose in Tapping Rate (Taps/Min)', 'timeFrame': 'Baseline and 34 minutes post-dose', 'description': 'One-minute tapping rate will be calculated as the number of times a subject could tap on two 4 x 4 cm marks placed on a board 30 cm apart during 1 minute (30 cm measured from the inner border of the two boxes).'}, {'measure': '"Success Rate" (Percentage of Subjects Achieving "Off" Reversals)', 'timeFrame': 'Up to 6 hours post-dose', 'description': 'Subjects reversing from "off" to "on" following initiation of treatment. "On" and "off" state refer to periods where Parkinson\'s disease symptoms are not present ("on") and periods where symptoms are present ("off"); the "on"/"off" determination at each assessment timepoint was made by the investigator.'}, {'measure': 'Time of First "Off" Reversal', 'timeFrame': 'Up to 6 hours post-dose', 'description': 'Number of minutes to first reversal of symptoms from "off" to "on". Estimated via Kaplan-Meier estimation method. "On" and "off" state refer to periods where Parkinson\'s disease symptoms are not present ("on") and periods where symptoms are present ("off"); the "on"/"off" determination at each assessment timepoint was made by the investigator.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rotigotine', 'Rotigotine nasal spray', 'Efficacy, safety and tolerability', "Parkinson's disease"], 'conditions': ["Parkinson's Disease"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The objective of this trial is to evaluate safety and efficacy of rotigotine nasal spray (SPM 952) in a single dose application scheme.\n\nSubjects will undergo a 2 - 28 days screening period in which eligibility criteria will be checked. Subjects will then be hospitalized for one night. In the morning of the next day, subjects will be randomly assigned either to rotigotine or placebo nasal spray and will then receive a single dose of trial medication. Safety assessments after application include adverse events, 12-lead electrocardiograms, blood pressure and heart rate assessments, and laboratory checks. Efficacy will be assessed by application of motor examination scores.\n\nThe first subject is planned to be enrolled in February 2006. The last subject is planned to be enrolled in May 2006. Last subject out is expected for August 2006.', 'detailedDescription': 'The objective of this trial is to evaluate safety and efficacy of rotigotine nasal spray (SPM 952)in a single dose application scheme. Subjects will undergo a 2-28 days screening period in which eligibility criteria will be checked. Subjects will then be hospitalized for one night. In the morning of the next day, subjects will be randomly assigned either to rotigotine or placebo nasal spray and will then receive a single dose of trial medication. Safety assessments after application include adverse events, 12-lead electrocardiograms, blood pressure and heart rate assessments, and laboratory checks. Efficacy will be assessed by application of motor examination scores.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female subjects with idiopathic Parkinson's disease for at least 3 years in duration\n* At least 30 years of age\n\nExclusion Criteria:\n\n* Patients with atypical Parkinson's or clinically relevant concomitant diseases or medical conditions"}, 'identificationModule': {'nctId': 'NCT00296192', 'briefTitle': 'Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of Parkinson Symptoms', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'A Double-Blind, Placebo-Controlled, Parallel-Group, Proof of Concept Trial to Assess the Tolerability, Safety, and Efficacy of Rotigotine Nasal Spray for the Acute Treatment of "OFF" Symptoms in Subjects With Advanced-Stage, Idiopathic Parkinson Disease', 'orgStudyIdInfo': {'id': 'SP0873'}, 'secondaryIdInfos': [{'id': 'EudraCT: 2005-004290-19', 'type': 'OTHER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo 1', 'description': 'Placebo nasal spray 1 - 4 puffs', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Rotigotine 1', 'description': 'Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)', 'interventionNames': ['Drug: Rotigotine nasal spray']}, {'type': 'EXPERIMENTAL', 'label': 'Rotigotine 2', 'description': 'Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)', 'interventionNames': ['Drug: Rotigotine nasal spray']}, {'type': 'EXPERIMENTAL', 'label': 'Rotigotine 3', 'description': 'Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)', 'interventionNames': ['Drug: Rotigotine nasal spray']}, {'type': 'EXPERIMENTAL', 'label': 'Rotigotine 4', 'description': 'Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)', 'interventionNames': ['Drug: Rotigotine nasal spray']}], 'interventions': [{'name': 'Rotigotine nasal spray', 'type': 'DRUG', 'otherNames': ['Neupro', 'SPM 952'], 'description': 'Rotigotine- HCl 2.5mg/mL nasal spray, dosage per puff of 275µg per 110µg administered in up to 4 deliveries', 'armGroupLabels': ['Rotigotine 1', 'Rotigotine 2', 'Rotigotine 3', 'Rotigotine 4']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'placebo nasal spray 1, 2 3, and 4 puffs', 'armGroupLabels': ['Placebo 1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'UCB Clinical Trial Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': '+1 877 822 9493 (UCB)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}