Effects of Talampanel on Patients With Advanced Parkinson's Disease
NCT ID: NCT00036296
Last Updated: 2011-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
22 participants
INTERVENTIONAL
2006-12-31
2007-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
75mg per day (in 3 doses) Talampanel for 22 days
talampanel
75mg per day divided into 3 doses for 22 days
2
3 doses a day for 22 days
talampanel
75mg per day divided into 3 doses for 22 days
Interventions
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talampanel
75mg per day divided into 3 doses for 22 days
Eligibility Criteria
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Inclusion Criteria
* 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
* Isolated or predominantly diphasic dyskinesias
* Moderate Dementia
* On disallowed concomitant medications including CYP3A4 inhibitors and inducers, amantadine, etc.
40 Years
85 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Teva Neuroscience
Other Identifiers
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IXL-202-18-189
Identifier Type: -
Identifier Source: org_study_id
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