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Effects of Talampanel on Patients With Advanced Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00036296
Recruitment Status : Completed
First Posted : May 9, 2002
Last Update Posted : April 13, 2011
Information provided by:
Teva Pharmaceutical Industries

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Dyskinesias Parkinson Disease Movement Disorders Drug: talampanel Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Study Start Date : December 2006
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
75mg per day (in 3 doses) Talampanel for 22 days
Drug: talampanel
75mg per day divided into 3 doses for 22 days

Placebo Comparator: 2
3 doses a day for 22 days
Drug: talampanel
75mg per day divided into 3 doses for 22 days

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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Responsible Party: Rivka Kreitman, Ph.D., Vice President, Innovative Research and Development, Teva Neuroscience Identifier: NCT00036296    
Other Study ID Numbers: IXL-202-18-189
First Posted: May 9, 2002    Key Record Dates
Last Update Posted: April 13, 2011
Last Verified: October 2009
Keywords provided by Teva Pharmaceutical Industries:
Involuntary Movements
Abnormal Movements
Advanced Parkinson's disease
Levodopa induced dyskinesia
Additional relevant MeSH terms:
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Parkinson Disease
Movement Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms