A Pilot Phase II Study for the evaluation of efficacy and tolerability of Gammaidroxybutyrate (ALCOVER) administered by oral route as add on treatmant in patients affected by DYT 11 Myoclonic Dystonia. - ND
- Conditions
- DYT 11 Myoclonic Dystonia.MedDRA version: 9.1Level: SOCClassification code 10029205Term: Nervous system disorders
- Registration Number
- EUCTR2006-001039-23-IT
- Lead Sponsor
- ISTITUTO NEUROLOGICO CARLO BESTA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Male and females > 17 years. Diagnosis of myoclonic dystonia genetically confirmed (mutation of epsilon sarcoglycan gene, 7q21-q31; DYT 11). Refractory to treatment with conventional medications. No contraindications to GHB. Written informed consent.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Serious medical and/or psychiatric diseases. More than two concomitant medications for myoclonic dystonia therapy and/or modifications of concomitant therapy in the last month prior to basal visit. Alcohol or drug abuse (last 2 years). Pregnant or lactating females. Subjects who received an experimantal drug or have participated in a clinical trial within 3 months prior to screening.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method