Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 4:36 PM
Study NCT ID:
NCT00203060
Status:
COMPLETED
Last Update Posted:
2011-04-12
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness, Tolerability and Safety of Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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': 'C031967', 'term': 'rasagiline'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 404}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2000-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-08', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2011-04-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary objective is to assess the safety and efficacy of rasagiline in PD subjects, not receiving or requiring carbidopa/levodopa therapy. The primary efficacy measure will be the change in total UPDRS score, calculated from baseline to 26 weeks.', 'timeFrame': '58 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "Study to look at the effectiveness, tolerability and safety of two doses of Study Medication in Early Parkinson's Disease (PD) Patients who have not been treated with Levodopa."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nMen and women with Parkinson's disease (PD) whose diagnosis is confirmed by at least two of the cardinal signs (resting tremor, bradykinesia, rigidity) being present, without other known or suspected cause of parkinsonism.\n\nSubjects must be age 35 years or older.\n\nSubjects not taking or requiring anti-parkinsonian medications, except for anticholinergics.\n\nExclusion Criteria:\n\nSubjects with unstable systemic medical problems or clinically significant malignancy, with particular attention to clinically significant or unstable vascular disease"}, 'identificationModule': {'nctId': 'NCT00203060', 'briefTitle': "Effectiveness, Tolerability and Safety of Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa", 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': "A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Phase III Clinical Trial For The Efficacy, Tolerability And Safety Of Two Doses Of Rasagiline Mesylate In Early Parkinson's Disease (PD) Patients Not Treated With Levodopa", 'orgStudyIdInfo': {'id': 'TVP-1012/232'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Rasagiline treatment', 'interventionNames': ['Drug: Rasagiline Mesylate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'description': 'placebo arm', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Rasagiline Mesylate', 'type': 'DRUG', 'description': 'tablet, 1 or 2 mg, daily, 58 weeks', 'armGroupLabels': ['A']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'tablet, once daily, 58 weeks', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sheila Oren, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Teva Pharmaceutical Industries, Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Neuroscience, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'J. Michael Nicholas, Ph.D. Sr. Director', 'oldOrganization': 'Teva Neuroscience'}}}}