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Sponsored by: |
University Health Network, Toronto |
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Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00296959 |
A phase II double blind trial to evaluate the effects of the AMPA, glutamte antagonist, topiramate on levodopa-induced dyskinesia in Parkinson's disease
Condition | Intervention | Phase |
---|---|---|
Parkinson's Disease |
Drug: topiramate (drug) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Anti-Dyskinetic Properties of Topiramate: A Double-Blind, Placebo-Controlled Trial in Patients With Parkinson's Disease and Levodopa-Induced Dyskinesias |
Estimated Enrollment: | 20 |
Study Start Date: | September 2004 |
Study Completion Date: | March 2007 |
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.
Ages Eligible for Study: | 30 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
Toronto Western Hospital, UHN | |
Toronto, Ontario, Canada, M5T 2S8 |
Principal Investigator: | Susan H Fox, MRCP, PhD | UHN, Toronto, Canada |
Study ID Numbers: | MDCTOP2005 |
Study First Received: | February 23, 2006 |
Last Updated: | September 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00296959 |
Health Authority: | Canada: Health Canada |
Dyskinesia AMPA receptor antagonists |
Levodopa Ganglion Cysts Basal Ganglia Diseases Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Dyskinesias |
Signs and Symptoms Parkinson Disease Movement Disorders Neurologic Manifestations Topiramate Parkinsonian Disorders |
Anti-Obesity Agents Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases Protective Agents |
Neuroprotective Agents Central Nervous System Agents Pharmacologic Actions Anticonvulsants |