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 range18 Years – 60 Years
SexALL
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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
What they're measuring
1
Measure of the evolution of the severity of myoclonus by a specific scale (UMRS)