Effects of Talampanel on Patients With Advanced Parkinson's Disease

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00036296

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dyskinesias Parkinson Disease Movement Disorders	Drug: talampanel	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

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)

Study Start Date :

Dec 1, 2006

Actual Primary Completion Date :

Feb 1, 2007

Actual Study Completion Date :

Feb 1, 2007

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.