Efficacy Trial of Zonisamide for Myoclonus Dystonia (NCT01806805) | Clinical Trial Compass
CompletedPhase 3
Efficacy Trial of Zonisamide for Myoclonus Dystonia
France24 participantsStarted 2012-02
Plain-language summary
Myoclonus Dystonia is a disease in which myoclonus distort the precision of movements and so cause a handicap in the movements of the everyday life. Response to oral medications may be incomplete and surgery may cause operating risk.
Zonisamide is an antiepileptic drug which could bring a therapeutic profit in Myoclonus Dystonia on the severity of the myoclonus.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria :
* Age \>18 and \< 60
* Diagnosis of myoclonus dystonia including the isolated myoclonus caused by epsilon-sarcoglycans mutation or deletion.
* Myoclonus present in both hands
* Myoclonus decrease quality of life
* Insufficient efficiency of the benzodiazepine's tolerated maximal dose during one year
* Agreement to use a medically acceptable method of contraception throughout the study for female of childbearing potential
* Normal physical and neurological examination, except myoclonus dystonia
* No hepatic disease
* No renal disease
* Able to comply with study visits and procedures
* Has voluntarily signed consent form
* Taking no medications or stable doses medication for 4 weeks prior to the Baseline visit
Exclusion criteria :
* Patients who are not enrolled at social security
* Individual who have MMS ≤ 24/30 or patients legally protected or inability to provide an informed consent
* Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control
* Weight \< 40 kg
* history of serious psychiatric illness
* history of renal stones
* history of allergy to sulfonamides
* taking medications : topiramate, rifampicin, ketoconazole, cimetidine
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Measure of the evolution of the severity of myoclonus by a specific scale (UMRS)