Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-27 @ 12:38 AM
Study NCT ID:
NCT00134251
Status:
COMPLETED
Last Update Posted:
2009-01-30
First Post:
2005-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ascending Dose Tolerability/Safety of SLV308 for the Treatment of Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Serbia and Montenegro']}, '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': 'C480679', 'term': 'pardoprunox'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'lastUpdateSubmitDate': '2009-01-29', 'studyFirstSubmitDate': '2005-08-22', 'studyFirstSubmitQcDate': '2005-08-22', 'lastUpdatePostDateStruct': {'date': '2009-01-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-24', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ["Parkinson's disease", 'adjunctive to L-dopa therapy', "Advanced stage Parkinson's disease"], 'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "This study is a multicenter, randomized, double-blind, placebo controlled, parallel group study of a seven-week ascending dose period of SLV308 adjunctive to L-dopa treatment in patients with advanced stage Parkinson's disease (PD) and dose-dependent motor fluctuations. Patients (outpatients) will be randomized to one of three different treatment arms."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have signed an informed consent; diagnosis of idiopathic PD.\n* Presence of recognizable "on" and "off" stages\n* Minimum hours of "off" time per day of 2.5 hours\n* Able to keep diaries.\n\nExclusion Criteria:\n\n* Unclear diagnosis or a suspicion of other parkinsonian syndromes\n* Have undergone surgical treatment for PD\n* History of non-response to L-dopa.'}, 'identificationModule': {'nctId': 'NCT00134251', 'briefTitle': "Ascending Dose Tolerability/Safety of SLV308 for the Treatment of Parkinson's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Solvay Pharmaceuticals'}, 'officialTitle': "A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Parallel Group Study Exploring Effects of SLV308 up to 42 mg/Day Administered as an Adjunctive Therapy to L-Dopa in Patients With Advanced Stage Parkinson's Disease", 'orgStudyIdInfo': {'id': 'S308.3.005'}, 'secondaryIdInfos': [{'id': 'EuDract no 2005-002432-10'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'SLV308', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Site 16', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Site 11', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Site 12', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Site 13', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Site 14', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Site 15', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Guardamangia', 'country': 'Malta', 'facility': 'Site 21'}, {'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Site 31', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Site 34', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Niš', 'country': 'Serbia', 'facility': 'Site 33', 'geoPoint': {'lat': 43.32472, 'lon': 21.90333}}], 'overallOfficials': [{'name': 'Global Clinical Director Solvay', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Solvay Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Solvay Pharmaceuticals', 'class': 'INDUSTRY'}}}}