Levetiracetam Treatment in Adult Subjects With Parkinson's Disease Experiencing Troublesome Dyskinesias

Idiopathic Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00160576
• Other study ID #: N01105
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: December 5, 2013
• Start date: July 2003
• Est. completion date: November 2004

Study information

• Verified date: September 2009
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Portugal: National Pharmacy and Medicines Institute
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2004
• Est. primary completion date: November 2004
• Gender: Both
• Age group: 30 Years and older

Eligibility

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;

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Dyskinesias
• Idiopathic Parkinson Disease
• Parkinson Disease

Intervention

Drug:
• Levetiracetam

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reduction in mean duration of dyskinesias per day at 9 month;Safety

External Links

•   Clinical Study Summary on UCB.com