Efficacy Trial of Zonisamide for Myoclonus Dystonia

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Zonisamide

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