Effects of Talampanel on Patients With Advanced Parkinson's Disease

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.

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Key information

Conditions

Dyskinesias Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Talampanel

Drug

75mg per day divided into 3 doses for 22 days

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2007
First posted: May 9, 2002
Registry last updated: Apr 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed