Overview

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