Status:
COMPLETED
Efficacy Trial of Zonisamide for Myoclonus Dystonia
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Myoclonus Dystonia
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
In "dystonia", the involuntary abnormal movements cause a driving handicap and a change of the quality of life. A particular shape of dystonia, the Myoclonus Dystonia, is characterized by the ascendan...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01806805
Start Date
February 1 2012
End Date
July 1 2014
Last Update
April 24 2015
Active Locations (1)
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1
Pitié salpetriere hospital
Paris, France, 75013