Effects of Talampanel on Patients With Advanced Parkinson's Disease

Parkinson Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00036296
• Other study ID #: IXL-202-18-189
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 8, 2002
• Last updated: April 11, 2011
• Start date: December 2006
• Est. completion date: February 2007

Study information

• Verified date: October 2009
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyskinesias
• Movement Disorders
• Parkinson Disease

Intervention

Drug:
• talampanel
75mg per day divided into 3 doses for 22 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Teva Pharmaceutical Industries