Effects of Talampanel on Patients With Advanced Parkinson's Disease

Phase 1

Completed

• Conditions: Dyskinesias; Parkinson Disease; Movement Disorders
• Interventions: Drug: talampanel

• Registration Number: NCT00036296
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2002-05-08
• Study First Submitted QC: 2002-05-08
• Study First Posted: 2002-05-09
• Study Start: 2006-12
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Status Verified: 2009-10
• Last Update Submitted: 2011-04-11
• Last Update Posted: 2011-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	talampanel	75mg per day (in 3 doses) Talampanel for 22 days
2	talampanel	3 doses a day for 22 days