Ignite Creation Date:
2025-12-25 @ 3:14 AM
Ignite Modification Date:
2026-01-08 @ 12:13 PM
Study NCT ID:
NCT02231905
Status:
COMPLETED
Last Update Posted:
2014-09-04
First Post:
2014-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and Efficacy of Switching From Talipexole to Pramipexole in Patients With 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'lastUpdateSubmitDate': '2014-09-03', 'studyFirstSubmitDate': '2014-09-03', 'studyFirstSubmitQcDate': '2014-09-03', 'lastUpdatePostDateStruct': {'date': '2014-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients who prematurely discontinued due to adverse event', 'timeFrame': 'up to 12 weeks'}], 'secondaryOutcomes': [{'measure': "Change of the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (activities of daily living)", 'timeFrame': 'up to 12 weeks'}, {'measure': 'Change of the sum of UPDRS Part III (motor examination)', 'timeFrame': 'up to 12 weeks'}, {'measure': 'Change of Modified Hoehn & Yahr scale', 'timeFrame': 'up to 12 weeks'}, {'measure': 'Change of Clinical global impression (CGI) of efficacy', 'timeFrame': 'up to 12 weeks'}, {'measure': 'Number of patients with abnormal changes in laboratory parameters', 'timeFrame': 'up to 12 weeks'}, {'measure': 'Number of patients with clinically significant changes in vital signs', 'timeFrame': 'up to 12 weeks', 'description': 'Blood Pressure, Pulse Rate'}, {'measure': 'Number of patients with adverse events', 'timeFrame': 'up to 12 weeks'}, {'measure': 'Number of patients with clinically significant changes in electrocardiogram (ECG)', 'timeFrame': 'up to 12 weeks'}]}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "Study to assess the safety, tolerability and effectiveness of a switching from Domin® (talipexole) tablet to BI Sifrol® (pramipexole) tablet in patients with Parkinson's disease"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosis of Parkinson's disease (included juvenile parkinsonism) and treated with talipexole (Domin®)\n2. Patients who present stable symptoms and maintain the doses of talipexole and other concomitant therapy for Parkinson's disease at least last 4 weeks\n3. Male or female patients aged 20 and over\n4. In or out-patients\n5. Patient's severity characterized as Stage 1 - 5 by Modified Hoehn \\& Yahr scale\n6. Ability to provide written informed consent in accordance with the Good Clinical Practice (GCP), Good Post-marketing Surveillance Practice (GPMSP) and other relevant laws such as the Pharmaceutical Affairs Law\n\nExclusion Criteria:\n\n1. History of hypersensitivity of pramipexole\n2. Psychiatric symptoms such as confusion, hallucination, delusion, agitation, delirium and abnormal behavior\n3. Subjective symptom derived from orthostatic hypotension\n4. Hypotension (systolic blood pressure; 100 mmHg or less)\n5. Complication such as clinically significant cardiac, renal and hepatic diseases\n6. Patients who drive a car, operate a machine, work on heights or engage in other hazardous activities\n7. Pregnant, possibly pregnant or female in lactation\n8. Patients who are participating in other drug studies or who receive other investigational drugs within last 3 months before enrolled this study\n9. Other than above, those who judged by the investigator or sub-investigator to be inappropriate as for the study"}, 'identificationModule': {'nctId': 'NCT02231905', 'briefTitle': "Safety, Tolerability and Efficacy of Switching From Talipexole to Pramipexole in Patients With Parkinson's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Open Label, Exploratory Clinical Trial to Assess the Safety, Tolerability and Effectiveness of a Switching From Talipexole to Pramipexole', 'orgStudyIdInfo': {'id': '248.544'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BI-Sifrol®', 'description': 'Tablets were administrated after switching from prior treatment of dopamine agonist (talipexole), treatment period consisted of an ascending period and a maintenance period, total duration was 4 to 12 weeks.', 'interventionNames': ['Drug: BI-Sifrol®']}], 'interventions': [{'name': 'BI-Sifrol®', 'type': 'DRUG', 'armGroupLabels': ['BI-Sifrol®']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}