Effects of Talampanel on Patients With Advanced Parkinson's Disease

April 11, 2011 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

This is where you will find people and organizations involved with this study.

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IXL-202-18-189

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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