Overview

Topiramate as a Treatment for Levodopa-Induced Dyskinesia in Parkinson's Disease

Status:
Terminated
Trial end date:
2007-03-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Health Network, Toronto
Treatments:
Levodopa
Topiramate
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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