Effects of Talampanel on Patients With Advanced Parkinson's Disease
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
22 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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