Effects of Talampanel on Patients With Advanced Parkinson's Disease - Full Text View

Sponsor:	Teva Pharmaceutical Industries
Information provided by:	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT00036296

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 I Phase II

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:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease Perry syndrome

MedlinePlus related topics: Movement Disorders Parkinson's Disease

Drug Information available for: GYKI 53773

U.S. FDA Resources

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

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:

Dyskinesias
Movement Disorders
Parkinson Disease
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations

Signs and Symptoms
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on February 12, 2012