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	Treatment or Intervention	Phase
Dyskinesias Parkinson Disease Movement Disorders	Drug: talampanel	Phase I Phase II

Ages Eligible for Study:  40 Years   -   85 Years,  Genders Eligible for Study:  Both

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.

Florida
      Parkinson's Disease Movement Disorder Center of Boca Raton, Boca Raton,  Florida,  33486,  United States
      Cleveland Clinic Florida, Weston,  Florida,  33331,  United States
Georgia
      Emory University School of Medicine, Atlanta,  Georgia,  30329,  United States
New York
      Beth Israel Medical Center, New York,  New York,  10003,  United States
      Mount Sinai School of Medicine, New York,  New York,  10029,  United States
Canada, Ontario
      Toronto Western Hospital, University Health Network, Toronto,  Ontario,  M5T 2S8,  Canada
      Center for Movement Disorder, Markham,  Ontario,  L6B 1A1,  Canada

Study ID Numbers:  IXL-202-18-189
Record last reviewed:  October 2003
Last Updated:  October 13, 2004
Record first received:  May 8, 2002
ClinicalTrials.gov Identifier:  NCT00036296
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08