Effects of Talampanel on Patients With Advanced Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00036296
First received: May 8, 2002
Last updated: April 11, 2011
Last verified: October 2009
  Purpose

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 Intervention Phase
Dyskinesias
Parkinson Disease
Movement Disorders
Drug: talampanel
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Enrollment: 22
Study Start Date: December 2006
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Rivka Kreitman, Ph.D., Vice President, Innovative Research and Development, Teva Neuroscience
ClinicalTrials.gov Identifier: NCT00036296     History of Changes
Other Study ID Numbers: IXL-202-18-189
Study First Received: May 8, 2002
Last Updated: April 11, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
Involuntary Movements
Abnormal Movements
Advanced Parkinson's disease
Levodopa induced dyskinesia

Additional relevant MeSH terms:
Parkinson Disease
Dyskinesias
Movement Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014