Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-28 @ 5:51 AM
Study NCT ID:
NCT00307450
Status:
COMPLETED
Last Update Posted:
2009-08-03
First Post:
2006-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Levetiracetam Versus Placebo on Levodopa-induced Dyskinesias in Advanced Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D020820', 'term': 'Dyskinesias'}], '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'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077287', 'term': 'Levetiracetam'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-31', 'studyFirstSubmitDate': '2006-03-27', 'studyFirstSubmitQcDate': '2006-03-27', 'lastUpdatePostDateStruct': {'date': '2009-08-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified AIMS', 'timeFrame': '11 weeks'}, {'measure': 'UPDRS items 32 & 33', 'timeFrame': '11 weeks'}], 'secondaryOutcomes': [{'measure': 'UPDRS', 'timeFrame': '11 weeks'}, {'measure': 'Schwab & England scale', 'timeFrame': '11 weeks'}, {'measure': 'Hoehn & Yahr scale', 'timeFrame': '11 weeks'}, {'measure': 'GCI', 'timeFrame': '11 weeks'}, {'measure': 'Patient day record', 'timeFrame': '11 weeks'}, {'measure': 'Epsworth sleep scale', 'timeFrame': '11 weeks'}, {'measure': 'Levodopa challenge test', 'timeFrame': '11 weeks'}, {'measure': 'Safety measures', 'timeFrame': '11 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dyskinesias', "Parkinson's disease", 'Levetiracetam', 'Treatment'], 'conditions': ["Parkinson's Disease"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.neuro.med.tu-dresden.de', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "The study is designed to measure the efficacy and safety of levetiracetam on levodopa-induced dyskinesias in late-stage Parkinson's disease. The patients are planned to be treated with levetiracetam (up to 2000 mg per day) or placebo for 13 weeks. Efficacy measure is the modified AIMS.", 'detailedDescription': "The LeLeDys study is designed to determine the efficacy and safety of levetiracetam on levodopa-induced dyskinesias in advanced Parkinson's disease.\n\nThe design is a multicenter, randomized, stratified, double-blinded, placebo-controlled phase IV study design.\n\nThe hypothesis is that levetiracetam is able to reduce duration and severity of levodopa-induced dyskinesias in Parkinson's disease.\n\nThe patients are planned to be treated with levetiracetam (up to 2000 mg per day) or placebo for 13 weeks. Efficacy measure is the modified AIMS.\n\nMain inclusion criteria are:\n\n* Advanced Parkinson's disease (Hoehn \\& Yahr II-IV)\n* Age of 30 to 80 years\n* Levodopa-induced dyskinesias of at least 25% of the waking day and with moderate disability\n* Stable dosage of antiparkinson medication and/or stable deep brain stimulation parameters for at least 4 week prior inclusion\n* Written informed consent\n\nMain exclusion criteria are:\n\n* Atypical parkinsonian syndromes\n* Treatment with antipsychotics\n* Epilepsia or seizure in the history\n* Deep brain stimulation other than DBS in STN\n* Pregnant or lactating women\n* Severe dementia\n\nMethods:\n\n* Primary outcome measure is the modified AIMS\n* Secondary outcome measures include UPDRS, safety, patient day record\n\nStudy medication:\n\n* Levetiracetam (upt to 2000 mg / day)\n* Matched Placebo"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Advanced Parkinson's disease (Hoehn \\& Yahr II-IV)\n* Age of 30 to 80 years\n* Levodopa-induced dyskinesias of at least 25% of the waking day and with moderate disability\n* Stable dosage of antiparkinson medication and/or stable deep brain stimulation parameters for at least 4 week prior inclusion\n* Written informed consent\n\nExclusion Criteria:\n\n* Atypical parkinsonian syndromes\n* Treatment with antipsychotics\n* Epilepsia or seizure in the history\n* Deep brain stimulation other than DBS in STN\n* Pregnant or lactating women\n* Severe dementia"}, 'identificationModule': {'nctId': 'NCT00307450', 'acronym': 'LeLeDys', 'briefTitle': "Efficacy and Safety of Levetiracetam Versus Placebo on Levodopa-induced Dyskinesias in Advanced Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'officialTitle': "Efficacy and Safety of Levetiracetam Versus Placebo on Levodopa-induced Dyskinesias in Advanced Parkinson's Disease (LeLeDys Study) - A Multicenter, Randomized, Stratified, Double-blinded, Placebo-controlled Phase IV Study", 'orgStudyIdInfo': {'id': 'TUD-LELEDY-007'}, 'secondaryIdInfos': [{'id': 'Ethic board no.: EK10012006'}, {'id': 'EUDRAC no.: 2005-005940-18'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Levetiracetam', 'type': 'DRUG', 'description': 'up to 200 mg per day in two dosages per day.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Department of Neurology at the Technical University of Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '04103', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Department of Neurology at the University of Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'overallOfficials': [{'name': 'Alexander Storch, M', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Technical University of Dresden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}, 'collaborators': [{'name': 'UCB Pharma GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Prof. Dr. med. Alexander Storch', 'oldOrganization': 'Dresden University of Technology'}}}}