Status:
TERMINATED
Topiramate as a Treatment for Levodopa-Induced Dyskinesia in Parkinson's Disease
Lead Sponsor:
University Health Network, Toronto
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30-75 years
Phase:
PHASE2
Brief Summary
A phase II double blind trial to evaluate the effects of the AMPA, glutamte antagonist, topiramate on levodopa-induced dyskinesia in Parkinson's disease
Detailed Description
The proposed study is a proof-of-concept, Phase II, randomized, double-blind, placebo-controlled, crossover trial to assess the anti-dyskinetic properties of topiramate in patients with PD and bothers...
Eligibility Criteria
Inclusion
- UK PD Society Brain Bank criteria for the diagnosis of idiopathic PD.
- Patients with stable levodopa-induced dyskinesias present greater than 25% of the day (Unified Parkinson's Disease Rating Scale (UPDRS), item 32, rating \> 2) and be moderately to completely disabling (UPDRS item 33, rating \> 2).
- All anti-parkinsonian medications must be stable for at least one month prior to study enrollment.
Exclusion
- Include prior surgery for PD
- Hoehn and Yahr score of 5 when "off"
- History of nephrolithiasis
- Renal impairment
- Liver disease
- Pregnancy
- Premenopausal females and males not using adequate contraception
- Cognitive impairment (Mini Mental State Exam score less than 24)
- History of glaucoma or seizures
- Use of other antiepileptic drugs
- Amantadine
- Carbonic anhydrase inhibitors
- Digoxin
- Metformin
- Or illicit drugs
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00296959
Start Date
September 1 2004
End Date
March 1 2007
Last Update
September 20 2007
Active Locations (1)
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1
Toronto Western Hospital, UHN
Toronto, Ontario, Canada, M5T 2S8