Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-25 @ 3:10 AM
NCT ID:
NCT01806805
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01806805
Study Brief:
Protocol Section:
NCT01806805