Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-26 @ 1:28 AM
Study NCT ID:
NCT00291733
Status:
UNKNOWN
Last Update Posted:
2007-11-15
First Post:
2006-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in 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': '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2007-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-11-14', 'studyFirstSubmitDate': '2006-02-14', 'studyFirstSubmitQcDate': '2006-02-14', 'lastUpdatePostDateStruct': {'date': '2007-11-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change of "on with levodopa-induced dyskinesias (LID)" time from patient diaries', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Percent change of "on without dyskinesias" and "off" time from patient diaries. Changes in severity and duration of LID according to the UPDRS , Schwab & England scale and also Goetz dyskinesia scale after a levodopa challenge dose.', 'timeFrame': '24 hours'}]}, 'conditionsModule': {'keywords': ['Levetiracetam', 'Levodopa-induced dyskinesias', "Parkinson's"], 'conditions': ['Levodopa Induced Dyskinesia']}, 'descriptionModule': {'briefSummary': 'Levodopa-induced dyskinesias have been associated with irregular oscillatory discharge characteristics of basal ganglia. From the other hand, LEV which shares a different electrophysiologic profile than other antiepileptics, inhibits hyper-synchronization of abnormal neuronal firing in experimental models of epilepsy. LEV also reduces levodopa-induced dyskinesias in MPTP-lesioned macaques and modulates "priming phenomenon" which associated with long-term changes in synaptic function that can lead to dyskinesias in PD.\n\nStudy objectives :\n\n* To evaluate the effects of levetiracetam (LEV) in two doses (500 and 1000mg) vs placebo on disabling dyskinesias that develop as result of long-term treatment with levodopa, occurring at the time of maximal clinical improvement in patients with Parkinson\'s disease (PD).\n* To evaluate the safety of LEV in patients with PD and antiparkinsonian medication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nDiagnosis of PD will be according to the criteria of United Kingdom Parkinson's Disease Society Brain Bank.\n\nOther inclusion criteria:\n\n* Patients between ages 30 and 80\n* Hoehn and Yahr stage of PD over IIb\n* Levodopa-induced dyskinesias (LID) despite optimization of antiparkinsonian medication\n* LID severity 2 on item 32 and duration 2 on item 33 of the Unified Parkinson's Disease Rating Scale (UPDRS) part IV\n* Patient is willing to adhere to protocol requirements as evidence by written informed consent\n\nExclusion Criteria:\n\n* Patient has a history of any medical condition or clinically significant laboratory abnormalities that can subject them to unwarranted risk.\n* Female patient is pregnant or breastfeeding or has not been using or was not continuing to use an adequate contraceptive method for the last 30 days, or is not at least one year post-menopausal.\n* Patient with ablative surgeries or DBS implantation electrodes for diseases of the basal ganglia.\n* Patient has a low Mini-mental Examination MMSE score \\<25 or has a history of bipolar psychosis or schizophrenia.\n* Patient is unwilling to sign an informed consent or to comply with protocol requirements.\n* Patient is taking or has taken in the past month amantadine."}, 'identificationModule': {'nctId': 'NCT00291733', 'briefTitle': "Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': '1st Hospital of Social Security Services'}, 'officialTitle': "Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease: A Double-Blind,Placebo-Controlled, Crossover Trial", 'orgStudyIdInfo': {'id': 'VALID-PD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': '500mg levetiracetam for one week and 1000mg levetiracetam for one week', 'interventionNames': ['Drug: Levetiracetam']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'After crossover arm 3 equals arm 1', 'interventionNames': ['Drug: Levetiracetam']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'description': 'After crossover arm 4 equals arm 2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Levetiracetam', 'type': 'DRUG', 'description': '500mg (2 tabl of 250) for one week and 1000mg (4 tabl of 250) for one week', 'armGroupLabels': ['1', '3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tabl', 'armGroupLabels': ['2', '4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '151-27', 'city': 'Athens', 'country': 'Greece', 'facility': 'Department of Neurology, 1st Hospital of Social Security Services', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'overallOfficials': [{'name': 'Pantelis Stathis, MD', 'role': 'STUDY_CHAIR', 'affiliation': '1st Hospital of Social Security Services'}, {'name': 'Spiros Konitsiotis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurology, University of Ioannina'}, {'name': 'Vasilis Kyriakakis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurology, General Hospital of Lamia'}, {'name': 'Georgios Tagaris, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurology, PGNA "Georgios Genimatas"'}, {'name': 'Kostas Papadopoulos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurology, Hospital of Mental Diseases of Tripolis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '1st Hospital of Social Security Services', 'class': 'OTHER'}, 'collaborators': [{'name': 'UCB Pharma', 'class': 'INDUSTRY'}]}}}