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

Tracking Information
First Received Date ^ICMJE	May 8, 2002
Last Updated Date	March 31, 2008
Start Date ^ICMJE
Primary Completion Date	February 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00036296 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Effects of Talampanel on Patients With Advanced Parkinson's Disease
Official Title ^ICMJE	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)
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.
Detailed Description	A randomized, double-blind, placebo-controlled, dose-escalating study to assess the efficacy and safety of Talampanel on levadopa-induced dyskinesias and to assess the optimal dose of Talampanel in Parkinsonian patients with dyskinesias.
Study Phase	Phase I, Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment
Condition ^ICMJE	Dyskinesias Parkinson Disease Movement Disorders
Intervention ^ICMJE	Drug: talampanel
Study Arms / Comparison Groups	Experimental: 75mg per day (in 3 doses) Talampanel for 22 days Placebo Comparator: 3 doses a day for 22 days
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	22
Completion Date
Primary Completion Date	February 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	40 Years to 85 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada

Administrative Information
NCT ID ^ICMJE	NCT00036296
Responsible Party	Rivka Kreitman, Ph.D., Vice President, Innovative Research and Development, Teva Neuroscience
Study ID Numbers ^ICMJE	IXL-202-18-189
Study Sponsor ^ICMJE	Teva Global Respiratory Research LLC
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Teva Global Respiratory Research LLC
Verification Date	March 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP