Much preparation happens before a study starts enrolling patients, so that milestone — when the hypothesis testing begins — is an important one. A study The Michael J. Fox Foundation funded earlier this year has reached that point, looking for participants to test a treatment for dyskinesia.
Dyskinesias are involuntary movements that develop as a side effect of long-term use of dopamine drugs (levodopa). Currently, the drug of choice to treat dyskinesia is amantadine. A recent study in pre-clinical models found that a readily available drug, topiramate, provided additional dyskinesia improvement with amantadine. In fact, the benefit of the combination of topiramate and amantadine proved to be better than the benefits from either one alone even when the individual effects were added.
Now Christopher G. Goetz, MD, and his team at Rush University Medical Center in Chicago are testing topiramate in Parkinson’s disease patients with dyskinesia who are already taking daily amantadine. They’re starting in Chicago and plan to enroll patients at sites in Tampa, Florida; Birmingham, Alabama; Durham, North Carolina; and Portland, Oregon.
Parkinson’s patients between ages 30 and 80 with dyskinesia, ranging from mild to severe, who have been on stable doses of amantadine for at least four weeks prior to study entry may be eligible. Participants will be assigned either placebo or topiramate, which will be gradually increased to a best dose that balances improvement and any potential side effects. The study will last 18 weeks and is double-blind, meaning neither patient nor researcher will know if each patient has received the placebo or the drug.
Researchers will monitor to see if the study drug has positive effects on dyskinesia and if study volunteers can safely and comfortably tolerate the two drugs in combination. Topiramate is approved by the U.S. Food and Drug Administration for the treatment of epilepsy and prevention of migraine headaches. Possible study results could lead to its use in Parkinson’s disease.
Learn more about this study.