Effects of Talampanel on Patients With Advanced Parkinson's Disease

NCT ID: NCT00036296

Last Updated: 2011-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-02-28

Brief Summary

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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

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Conditions

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Dyskinesias Parkinson Disease Movement Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

75mg per day (in 3 doses) Talampanel for 22 days

Group Type EXPERIMENTAL

talampanel

Intervention Type DRUG

75mg per day divided into 3 doses for 22 days

2

3 doses a day for 22 days

Group Type PLACEBO_COMPARATOR

talampanel

Intervention Type DRUG

75mg per day divided into 3 doses for 22 days

Interventions

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talampanel

75mg per day divided into 3 doses for 22 days

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Teva Neuroscience

Other Identifiers

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IXL-202-18-189

Identifier Type: -

Identifier Source: org_study_id

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