Official Title: “Effects of Talampanel on Patients With Advanced Parkinson's Disease Who Have Been on Sinemet for More Than 5 Years and Have Dyskinesia (Abnormal Involuntary Movements)”

The purpose of this research study is to test the safety and effectiveness of the study drug, Talampanel, when used to treat patients with involuntary movements known as dyskinesias, as a result of treatment to Parkinson's disease.

It is not clear why people with Parkinson's disease develop involuntary movements (dyskinesias) but studies show that blocking receptors in the brain for a chemical called glutamate decreases these movements. Talampanel is a drug which blocks these receptors.

Study Type: Interventional

Study Design: Treatment

Study Primary Completion Date: February 2007

A randomized, double-blind, placebo-controlled, dose-escalating study to assess the efficacy and safety of Talampanel on levadopa-induced dyskinesias and to assess the optimal dose of Talampanel in Parkinsonian patients with dyskinesias.

Intervention(s) in this Clinical Trial

• Drug: talampanel
  • 75mg per day divided into 3 doses for 22 days

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 75mg per day (in 3 doses) Talampanel for 22 days
• Placebo Comparator: 2
  • 3 doses a day for 22 days

Inclusion Criteria:

• Troublesome on-period dyskinesias as defined by a Unified Parkinson's Disease Rating Scale (UPDRS) dyskinesia sub-score >25% of Duration of dyskinesia during waking hours and 33 must have moderate disability
• Lang-Fahn dyskinesia rating score more than 2 for at least two of the 5 tasks
• Must have Dyskinesia on average 25% of waking hours/day based on Patient Diaries
• Have been diagnosed with Parkinson's disease > 5 years at Screening

Exclusion Criteria:

• Previous surgical therapies for PD
• Isolated or predominantly diphasic dyskinesias
• Moderate Dementia
• On disallowed concomitant medications including CYP3A4 inhibitors and inducers, amantadine, etc.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Teva Global Respiratory Research LLC

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00036296

Study ID Number: IXL-202-18-189

ClinicalTrials.gov Identifier: NCT00036296

Health Authority: United States: Food and Drug Administration