Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2026-02-26 @ 6:29 AM
Study NCT ID:
NCT00036218
Status:
COMPLETED
Last Update Posted:
2006-06-07
First Post:
2002-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early 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': 'C108539', 'term': 'U 95666E'}, {'id': 'C046649', 'term': 'ropinirole'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-12'}, 'statusVerifiedDate': '2006-06', 'completionDateStruct': {'date': '2003-04'}, 'lastUpdateSubmitDate': '2006-06-06', 'studyFirstSubmitDate': '2002-05-08', 'studyFirstSubmitQcDate': '2002-05-08', 'lastUpdatePostDateStruct': {'date': '2006-06-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-05-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change from baseline in UPDRS (Unified Parkinson's Disease Rating Scale) II + III total scores at end of maintenance, for sumanirole compared to placebo"}], 'secondaryOutcomes': [{'measure': 'To assess the safety profile of sumanirole; the benefit of sumanirole in quality of life measures, and change from baseline in UPDRS II + III total scores at end of maintenance, for sumanirole compared to ropinirole'}]}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=666E-CNS-0075-021&StudyName=Study+evaluating+sumanirole+for+the+treatment+of+the+signs+and+symptoms+of+early+Parkinson%27s+disease%2E', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': "The primary purpose of this study is to determine whether sumanirole is effective and safe in the treatment of the signs and symptoms of early Parkinson's disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nParkinson's disease of less than 7 years duration\n\nModified Hoehn and Yahr Scale Stages 1 through 3.\n\nAge greater than or equal to 30 years old.\n\nMen or women (women of childbearing potential must have a negative pregnancy test at screen) and both must use adequate contraceptive methods.\n\nPatients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\nAtypical Parkinson's disease syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases.\n\nLevodopa received for 1-year accumulated interval in the last two years.\n\nDopamine agonist medications or catechol-o-methyl transferase inhibitors in the 30 days prior to baseline.\n\nUnstable dose regimes of hypnotics, anxiolytics or antidepressants\n\nDementia\n\nHistory of stereotaxic brain surgery, psychosis or active epilepsy within past year.\n\nParticipation in clinical trial within the previous 30 days.\n\nMalignant melanoma or history of melanoma\n\nSignificant medical or pshychiatric condition."}, 'identificationModule': {'nctId': 'NCT00036218', 'briefTitle': "Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease.", 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': "A Phase III, Double-Blind, Placebo-Controlled, Randomized Study Comparing the Efficacy, Safety, and Tolerability of Sumanirole Versus Placebo or Ropinirole in Patients With Early Parkinson's Disease.", 'orgStudyIdInfo': {'id': '666E-CNS-0075-021'}}, 'armsInterventionsModule': {'interventions': [{'name': 'sumanirole', 'type': 'DRUG'}, {'name': 'ropinirole', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '95608', 'city': 'Carmichael', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.61713, 'lon': -121.32828}}, 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