Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-28 @ 2:34 PM
Study NCT ID:
NCT00228150
Status:
COMPLETED
Last Update Posted:
2008-12-23
First Post:
2005-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Effect of SR57667B on the Progression of Symptoms 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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 564}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-12-22', 'studyFirstSubmitDate': '2005-09-26', 'studyFirstSubmitQcDate': '2005-09-26', 'lastUpdatePostDateStruct': {'date': '2008-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to disability warranting introduction of Ldopaor a dopamine agonist.'}], 'secondaryOutcomes': [{'measure': "Unified Parkinson's Disease Rating Scale (UPDRS)"}]}, 'conditionsModule': {'keywords': ['Parkinson Disease', 'levodopa', 'dopamine agonists'], 'conditions': ['Parkinson Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sanofi-aventis.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to assess the effect of SR57667B at the dose of 4 mg/d on the progression of Parkinson symptoms in patients with early PD. The primary outcome will be the time to progression of disability warranting initiation of L-dopa or a dopamine agonist. Secondary outcomes will comprise assessments of symptoms, activities of daily living and global clinical status.', 'detailedDescription': 'Multinational, multicenter, randomized, parallel-group, double-blind, phase II study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female outpatients.\n* Age \\>=35 years at screening.·\n* Diagnosis of Parkinson's syndrome, on at least two of the three key Parkinson's symptoms, i.e. resting tremor, bradykinesia and rigidity.\n* Duration of the disease of less than 3 years since diagnosis·\n* Modified Hoehn and Yahr stage \\<= 2.5.\n* Untreated patients.\n* Generally healthy and ambulatory.\n* Patient has given his informed written consent and is capable of following study procedures.\n\nExclusion Criteria:\n\n* Any indication of forms of parkinsonism other than PD.\n* Severe resting tremor.\n* Presence of either dyskinesia, fluctuations, or loss of postural reflexes·\n* Treatment with L-Dopa, dopamine agonist, amantadine, anticholinergics, catechol-o-methyltransferase (COMT ) inhibitors, selegiline, dopamine receptor antagonists, catecholamine depleters, indirect dopamine agonists or alphamethyldopa.\n* Electroconvulsive therapy (ECT).\n* Use of CYP3A4 strong, and moderate inducers or inhibitors.\n* Participation in another clinical trial with an investigational drug within two months prior to randomization.\n* Dementia, uncontrolled depression, psychotic disorder.\n* History of substance-related disorders including alcohol or other substance use disorders.\n* Females of child bearing potential.\n* Evidence (detected by history, physical examination and/or laboratory/ECG tests) of any clinically significant or unstable medical disorder that could interfere with the patient's participation in the clinical trial; interfere with the absorption, metabolism or excretion of the study medication; or interfere with the evaluation of the study drug.\n* Alterations of laboratory tests or ECG findings of potential clinical significance."}, 'identificationModule': {'nctId': 'NCT00228150', 'briefTitle': "Study of the Effect of SR57667B on the Progression of Symptoms in Patients With Parkinson's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': "A Phase II, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy, Safety and Tolerability Study of SR57667B in Outpatients With Early Parkinson's Disease", 'orgStudyIdInfo': {'id': 'EFC5287'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SR57667B', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'country': 'Austria', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Laval', 'country': 'Canada', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 45.56995, 'lon': -73.692}}, {'city': 'Hørsholm', 'country': 'Denmark', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 55.88098, 'lon': 12.50111}}, {'city': 'Paris', 'country': 'France', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Casablanca', 'country': 'Morocco', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 33.58831, 'lon': -7.61138}}, {'city': 'Gouda', 'country': 'Netherlands', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 52.01667, 'lon': 4.70833}}, {'city': 'Porto Salvo', 'country': 'Portugal', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 38.72293, 'lon': -9.30473}}, {'city': 'Midrand', 'country': 'South Africa', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': -25.976, 'lon': 28.118}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Bromma', 'country': 'Sweden', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 59.34, 'lon': 17.94}}, {'city': 'Mégrine', 'country': 'Tunisia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 36.76917, 'lon': 10.23639}}, {'city': 'Guilford Surrey', 'country': 'United Kingdom', 'facility': 'Sanofi-Aventis Administrative Office'}], 'overallOfficials': [{'name': 'Mark GUTMAN, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Scientific Advisory Committee'}, {'name': 'Werner POEWE, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Scientific Advisory Committee'}, {'name': 'Olivier RASCOL, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Scientific Advisory Committee'}, {'name': 'Eduardo TOLOSA, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Scientific Advisory Committee'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'ICD Study Director', 'oldOrganization': 'sanofi-aventis'}}}}