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A phase II double blind trial to evaluate the effects of the AMPA, glutamte antagonist, topiramate on levodopa-induced dyskinesia in Parkinson's disease
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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 bothersome levodopa-induced dyskinesias.
Patients will be randomized to receive tablets of either placebo or topiramate in a double-blind, crossover design using randomization tables. Following the completion of the first arm of the study and the tapering and washout phases, patients will receive topiramate or placebo in a crossover design for the same treatment duration. The dose of topiramate will be slowly escalated twice each week as tolerated. If a patient cannot tolerate a higher dose, the dose will be reduced to the previously tolerated dose.
Clinical assessments during each arm of the study will include the following:
In addition, for safety monitoring, laboratory tests including urinalysis, clinical chemistries (sodium, potassium, chloride, bicarbonate, BUN, creatinine), CBC with differential, and liver function tests will be followed. These studies will be evaluated at the beginning and end of each treatment arm and mid-way through each dose escalation phase. A baseline EKG will be obtained, and repeat EKGs will be obtained at the completion of each treatment arm.
Results from this study will aid in the development of a larger Phase III clinical trial.
From the proposed trial, information regarding the anti-dyskinetic efficacy of topiramate will be obtained, and tolerability in the PD patient population will be determined.
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Data sourced from clinicaltrials.gov
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