Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-03-07 @ 11:22 AM
Study NCT ID:
NCT02248220
Status:
COMPLETED
Last Update Posted:
2014-09-25
First Post:
2014-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Tolerability of Sifrol® (Pramipexole) in Patients With Advanced Idiopathic Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 657}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'lastUpdateSubmitDate': '2014-09-22', 'studyFirstSubmitDate': '2014-09-22', 'studyFirstSubmitQcDate': '2014-09-22', 'lastUpdatePostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1999-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in cumulative daily doses of Sifrol®', 'timeFrame': 'up to 8 weeks', 'description': "Changes in the doses between visits are evaluated using Wilcoxon's signed rank test"}, {'measure': 'Changes in cumulative daily doses of L-dopa', 'timeFrame': 'up to 8 weeks', 'description': "Changes in the doses between visits are evaluated using Wilcoxon's signed rank test"}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Short Parkinson Evaluation Scale (SPES) total score', 'timeFrame': 'Baseline, after 8 weeks'}, {'measure': 'Change from Baseline in SPES subscales', 'timeFrame': 'Baseline, after 8 weeks', 'description': 'Psychopathological disturbances, Activities of daily living, Evaluation of motor function, Tremor, Resting Tremor, Postural tremor, Complications of therapy'}, {'measure': 'Change from Baseline in Snaith-Hamilton-Pleasure-Scale total score', 'timeFrame': 'Baseline, after 8 weeks', 'description': 'patients with SPES depression \\>= 2'}, {'measure': 'Change from Baseline in Tremor Impact Scale (TIS-D) total score', 'timeFrame': 'Baseline, after 8 weeks'}, {'measure': "Change from Baseline in global Parkinson's Disease (PD) symptoms", 'timeFrame': 'Baseline, after 8 weeks', 'description': 'Akinesia, anhedonia, depression, dyskinesia, motor fluctuation, cognitive disturbances, rigor and tremor'}, {'measure': 'Global assessment of efficacy by investigator on a 5-point scale', 'timeFrame': 'after 8 weeks'}, {'measure': 'Global assessment of tolerability by investigator on a 5-point scale', 'timeFrame': 'after 8 weeks'}, {'measure': 'Number of patients with adverse events', 'timeFrame': 'up to 8 weeks'}, {'measure': 'Number of patients with adverse drug reactions', 'timeFrame': 'up to 8 weeks'}]}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': 'Assessment of daily maintenance dose of Sifrol®, L-dopa sparing effect, effect on tremor, depression, anhedonia and tolerability'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients with advanced idiopathic Parkinson's diease recruited at specialist practices and hospitals", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with advanced idiopathic Parkinson's disease for whom combined treatment with Sifrol and L-dopa was indicated\n\nExclusion Criteria:\n\n* NA"}, 'identificationModule': {'nctId': 'NCT02248220', 'briefTitle': "Efficacy and Tolerability of Sifrol® (Pramipexole) in Patients With Advanced Idiopathic Parkinson's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': "Observation of the Efficacy and Tolerability of Sifrol® (Pramipexole) in Patients With Advanced Idiopathic Parkinson's Disease", 'orgStudyIdInfo': {'id': '248.360'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Parkinson's disease patients", 'interventionNames': ['Drug: Pramipexole']}], 'interventions': [{'name': 'Pramipexole', 'type': 'DRUG', 'otherNames': ['Sifrol®'], 'armGroupLabels': ["Parkinson's disease patients"]}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}