Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-30 @ 2:31 AM
Study NCT ID:
NCT00335166
Status:
COMPLETED
Last Update Posted:
2008-04-03
First Post:
2006-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SLV 308 and Pramipexole for Treatment of Patients With Early Parkinson 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': 'D000077487', 'term': 'Pramipexole'}], 'ancestors': [{'id': 'D052160', 'term': 'Benzothiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 330}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-04-01', 'studyFirstSubmitDate': '2006-06-08', 'studyFirstSubmitQcDate': '2006-06-08', 'lastUpdatePostDateStruct': {'date': '2008-04-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'UPDRS part 2 (ADL score); CGI-Improvement; PDQ-39 total score: all change from baseline to 24 weeks maintenance treatment.', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Parkinson Disease'], 'conditions': ['Early Stage Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '21542016', 'type': 'DERIVED', 'citation': "Sampaio C, Bronzova J, Hauser RA, Lang AE, Rascol O, van de Witte SV, Theeuwes AA; Rembrandt/Vermeer Study Groups. Pardoprunox in early Parkinson's disease: results from 2 large, randomized double-blind trials. Mov Disord. 2011 Jul;26(8):1464-76. doi: 10.1002/mds.23590. Epub 2011 May 3."}]}, 'descriptionModule': {'briefSummary': "This is a multicenter, randomized, double blind, parallel group study of 6 months' treatment with SLV308 as monotherapy in patients with early stage PD. An open label safety extension to this study is planned as a separate protocol for patients who are willing and eligible to participate."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of idiopathic Parkinson's Disease, Modified Hoehn \\& Yahr up to stage III, UPDRS motor score (part III) must have a total of at least 10 at baseline.\n\nExclusion Criteria:\n\n* Diagnosis is unclear or a suspicion of other parkinsonian syndromes,\n* Patients who have undergone surgery for the treatment of PD,\n* Current presence of dyskinesias,\n* Motor fluctuations or loss of postural reflexes,\n* A history of non-response to an adequate course of l-dopa or a dopamine agonist,\n* Patients for whom previously treatment with dopamine agonists needed to terminate because of induction of psychosis (i.e. hallucinations) and /or sleep attacks."}, 'identificationModule': {'nctId': 'NCT00335166', 'briefTitle': 'SLV 308 and Pramipexole for Treatment of Patients With Early Parkinson Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Solvay Pharmaceuticals'}, 'officialTitle': "A Multicenter, Randomized, Double Blind, Parallel-Group Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients With Early Stage Parkinson's Disease.", 'orgStudyIdInfo': {'id': 'S308.3.003'}, 'secondaryIdInfos': [{'id': 'Not requested yet'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Pardaprunox']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: pramipexole']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'interventionNames': ['Drug: Placebo Comparator']}], 'interventions': [{'name': 'Pardaprunox', 'type': 'DRUG', 'description': '12-42 mg', 'armGroupLabels': ['1']}, {'name': 'pramipexole', 'type': 'DRUG', 'description': '1.5-4.5 mg', 'armGroupLabels': ['2']}, {'name': 'Placebo Comparator', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': '419', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': '413', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'city': 'Oxnard', 'state': 'California', 'country': 'United States', 'facility': '408', 'geoPoint': {'lat': 34.1975, 'lon': -119.17705}}, {'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': '422', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': '403', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': '411', 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