Effects of Talampanel on Patients With Advanced Parkinson's Disease

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 Overview

• Status: Completed
• Conditions: Parkinson Disease; Movement Disorders; Dyskinesias
• Intervention / Treatment: Drug: talampanel

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

Collaborators and Investigators

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): February 1, 2007
• Study Completion (Actual): February 1, 2007

Study Registration Dates

• First Submitted: May 8, 2002
• First Submitted That Met QC Criteria: May 8, 2002
• First Posted (Estimate): May 9, 2002

Study Record Updates

• Last Update Posted (Estimate): April 13, 2011
• Last Update Submitted That Met QC Criteria: April 11, 2011
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: Advanced Parkinson's disease; Levodopa induced dyskinesia; Involuntary Movements; Abnormal Movements
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Dyskinesias; Movement Disorders
• Other Study ID Numbers: IXL-202-18-189