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Sponsored by: |
UCB |
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Information provided by: | UCB |
ClinicalTrials.gov Identifier: | NCT00160576 |
This is a 41-week trial composed of two consecutive parts (Part A, 14 weeks and optional Part B, 27 weeks) to evaluate the efficacy of levetiracetam in controlling levodopa induced dyskinesias in adults with Idiopathic Parkinson's Disease, without negative impact on the benefit on the motor function of the antiparkinsonian treatment.
Condition | Intervention | Phase |
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Idiopathic Parkinson Disease |
Drug: Levetiracetam |
Phase II |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | A Therapeutic Exploratory, Single Arm, Multicenter Trial to Evaluate the Efficacy and Safety of Levetiracetam up to 4000 mg/Day (500mg Oral Tablets) on Levodopa Induced Dyskinesias in Adults With Idiopathic Parkinson's Disease |
Estimated Enrollment: | 30 |
Study Start Date: | July 2003 |
Study Completion Date: | November 2004 |
Primary Completion Date: | November 2004 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Subject experiencing during .on. periods, despite several attempts of treatment adjustment, persistent troublesome dyskinesias:
Exclusion Criteria:
Study ID Numbers: | N01105 |
Study First Received: | September 8, 2005 |
Last Updated: | March 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00160576 |
Health Authority: | Belgium: Directorate general for the protection of Public health: Medicines; France: Afssaps - French Health Products Safety Agency; Portugal: National Pharmacy and Medicines Institute |
Idiopathic Parkinson's Disease, levodopa induced dyskinesia, Levetiracetam, Keppra |
Levodopa Ganglion Cysts Basal Ganglia Diseases Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Dyskinesias |
Signs and Symptoms Parkinson Disease Movement Disorders Piracetam Neurologic Manifestations Etiracetam Parkinsonian Disorders |
Nootropic Agents Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases Protective Agents |
Neuroprotective Agents Central Nervous System Agents Pharmacologic Actions Anticonvulsants |