Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:44 AM
Study NCT ID:
NCT00140218
Status:
COMPLETED
Last Update Posted:
2008-01-08
First Post:
2005-08-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': True}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-05', 'studyFirstSubmitDate': '2005-08-30', 'studyFirstSubmitQcDate': '2005-08-30', 'lastUpdatePostDateStruct': {'date': '2008-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ALS-FRSr score taken each month for 3 months during lead-in and for 6 months during treatment', 'timeFrame': '-3 -2 -1 0 1 2 3 4 5 6 months'}], 'secondaryOutcomes': [{'measure': 'FVC taken each month', 'timeFrame': '-3 -2 -1 0 1 2 3 4 5 6 months'}, {'measure': 'hand dynamometry taken each month', 'timeFrame': '-3 -2 -1 0 1 2 3 4 5 6'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['amyotrophic lateral sclerosis', 'pramipexole', 'oxidative stress', 'neuroprotection'], 'conditions': ['Amyotrophic Lateral Sclerosis']}, 'descriptionModule': {'briefSummary': 'The hypothesis of this study is that treatment with R(+) pramipexole at 30 mg/day will alter the slope of decline in ALS functional rating scale over the course of 6 months. ALS patients at an early stage of disease will be observed for 3 months after enrollment and then treated with drug for 6 months.', 'detailedDescription': 'This is a futility design Phase II study using ALS-FRSr as the primary variable to monitor progression of disease in patients with early ALS. The drug to be tested is R(+) pramipexole, an antioxidant that concentrates into brain and mitochondria. R(+)PPX will be administered at 30 mg/day over 6 months, following a 3 month lead-in period without drug therapy. For purposes of this study, futility is defined as failure to decrease the slope of ALS-FRSr decline by less than 40%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* established diagnosis of ALS FVC\\>60% of predicted not being ventilated no difficulty swallowing ambulatory (can use assistance devices)\n\nExclusion Criteria:\n\n* ALS duration \\>3 years advanced ALS with survival predicted \\<6 months dementia (MMSE\\<22) prior exposure to R(+) pramipexole orthostatic hypotension \\>30 mmHg history of psychosis or hallucinations abnormal baseline safety lab values'}, 'identificationModule': {'nctId': 'NCT00140218', 'briefTitle': 'R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis', 'organization': {'class': 'INDIV', 'fullName': 'Bennett, James P., Jr., M.D., Ph.D.'}, 'officialTitle': 'Futility Study of R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis', 'orgStudyIdInfo': {'id': '11736'}}, 'armsInterventionsModule': {'interventions': [{'name': 'R(+) pramipexole dihydrochloride monohydrate', 'type': 'DRUG', 'description': '10 mg tid oral'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'David Lacomis MD', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Lawrence H Phillips, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bennett, James P., Jr., M.D., Ph.D.', 'class': 'INDIV'}, 'collaborators': [{'name': 'University of Pittsburgh', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'James P. Bennett Jr. M.D. Ph.D. Sponsor', 'oldOrganization': 'University of Virginia'}}}}