Effects of Talampanel on Patients With Advanced Parkinson's Disease - Full Text View

Sponsored by:	IVAX Research LLC
Information provided by:	IVAX Research LLC
ClinicalTrials.gov Identifier:	NCT00036296

Purpose

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	Intervention	Phase
Dyskinesias Parkinson Disease Movement Disorders	Drug: talampanel	Phase I Phase II

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Movement Disorders Parkinson's Disease

Drug Information available for: Levodopa Sinemet

U.S. FDA Resources

Study Type:	Interventional
Study Design:	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)

Further study details as provided by IVAX Research LLC:

Enrollment:	22
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 75mg per day (in 3 doses) Talampanel for 22 days	Drug: talampanel 75mg per day divided into 3 doses for 22 days
2: Placebo Comparator 3 doses a day for 22 days	Drug: talampanel 75mg per day divided into 3 doses for 22 days

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	40 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036296

Locations

United States, Florida
Parkinson's Disease Movement Disorder Center of Boca Raton
Boca Raton, Florida, United States, 33486
Cleveland Clinic Florida
Weston, Florida, United States, 33331
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30329
United States, New York
Beth Israel Medical Center
New York, New York, United States, 10003
Mount Sinai School of Medicine
New York, New York, United States, 10029
Canada, Ontario
Toronto Western Hospital, University Health Network
Toronto, Ontario, Canada, M5T 2S8
Center for Movement Disorder
Markham, Ontario, Canada, L6B 1A1

Sponsors and Collaborators

IVAX Research LLC

More Information

Responsible Party:	Teva Neuroscience ( Rivka Kreitman, Ph.D., Vice President, Innovative Research and Development )
Study ID Numbers:	IXL-202-18-189
Study First Received:	May 8, 2002
Last Updated:	March 31, 2008
ClinicalTrials.gov Identifier:	NCT00036296
Health Authority:	United States: Food and Drug Administration

Keywords provided by IVAX Research LLC:

Involuntary Movements
Abnormal Movements
Advanced Parkinson's disease
Levodopa induced dyskinesia

Study placed in the following topic categories:

Levodopa
Ganglion Cysts
Basal Ganglia Diseases
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Dyskinesias

Signs and Symptoms
Parkinson Disease
Movement Disorders
Sinemet
Neurologic Manifestations
Parkinsonian Disorders

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009