Efficacy Trial of Zonisamide for Myoclonus Dystonia (EpsilonZêta)
Myoclonus Dystonia
About this trial
This is an interventional treatment trial for Myoclonus Dystonia focused on measuring Movement disorder, Myoclonus dystonia, DYT 11, Antiepileptic drugs, Zonisamide, Clinical Trial, Double-mind method
Eligibility Criteria
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
Sites / Locations
- Pitié salpetriere hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Zonegran
placebo
Zonegran / Placebo Zonisamide (Zonegran ®) and its placebo appear under the shape of virgin capsules of size 1. Each drug will be dispensed successively in a box containing blister packs of 14 capsules. For every period (A and B), box will contain 26 blister packs. A phase of progressive increase of doses by stages of 50 mg / week is planned before reaching the fixed dose of 300 in the daytime during 4 weeks. Then, a progressive diminution over two weeks is planned before the stop.
Placebo /Experimental Zonisamide (Zonegran ®) and its placebo appear under the shape of virgin capsules of size 1. Each drug will be dispensed successively in a box containing blister packs of 14 capsules. For every period (A and B), box will contain 26 blister packs. A phase of progressive increase of doses by stages of 50 mg / week is planned before reaching the fixed dose of 300 in the daytime during 4 weeks. Then, a progressive diminution over two weeks is planned before the stop.