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”

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.

Study Type: Interventional

Study Design: Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Study Primary Completion Date: November 2004

Intervention(s) in this Clinical Trial

• Drug: Levetiracetam

Primary Measures

• Evaluate the efficacy of levetiracetam in controlling levodopa induced dyskinesias in adults with Idiopathic Parkinson's Disease by assessing the reduction in mean duration of dyskinesias during "on" period at 10-week

Secondary Measures

• Reduction in mean duration of dyskinesias per day at 9 month;Safety

Inclusion Criteria:

• 1. Male / female adult, 30 years old or more;
• 2. Subject suffering from Idiopathic Parkinson's Disease, diagnosed according to the UK
• Brain Bank Criteria (see Appendix 14.8) (1) , since a minimum of 3 years, and stabilized with regard to the motor function (ratio .on./.off. over the day);
• 3. Subject treated with levodopa whether or not combined with any other antiparkinsonian drugs (except apomorphine) for minimum one year;
• 4. Subject experiencing during .on. periods, despite several attempts of treatment adjustment, persistent troublesome dyskinesias:
• 1. with a minimum score of 2 on item 33 of the UPDRS-Part IV (moderately disabling dyskinesias);
• 2. with a minimum score of 2 on item 32 of the UPDRS-Part IV (dyskinesias present during more than 25% of the waking day).

Exclusion Criteria:

• 1. Dyskinesias that cannot reliably be characterized on a regular basis by the subject himself/herself (more than 5 .errors. on DRC per 24 hours after repeated training);
• 2. Subject currently treated with apomorphine or neuroleptic drugs either typical or atypical such as clozapine, olanzapine or risperidone;
• 3. Subject currently treated with dopamine antagonists such as but not limited to metoclopramide, alizapride or phenothiazine derivatives (e.g. metopimazine). If necessary, the use of the dopamine antagonist domperidone is allowed.
• 4. Subject Who had undergone or who was scheduled for functional neurosurgery for
• Parkinson's disease during the trial period;

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: N/A

Lead Sponsor: UCB

Overall Clinical Trial Officials and Contacts

Françoise Tonner, MD Study Director unaffiliated  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00160576

Study ID Number: N01105

ClinicalTrials.gov Identifier: NCT00160576

Health Authority: Belgium: Directorate general for the protection of Public health: Medicines