Effect of vitamin D deficiency compensation in the treatment of drug-resistant epilepsy. - Epi-D
- Conditions
- Patients suffering from drug-resistant epilepsy.Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2017-001019-35-FR
- Lead Sponsor
- Centre Hospitalier Sainte-Anne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
- Age> 15 years
- At least 6 unprovoked crises in the 3 months prior to inclusion
- Syndromic diagnosis of established epilepsy
- Stable antiepileptic treatment during the 3 months prior to inclusion
- Absence of vitamin D treatment in the 6 months prior to inclusion.
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150
- Epilepsy surgery scheduled within 12 months
- Status of epilepticus in the 2 years preceding the study
- Treatments influencing the metabolism of vitamin D other than anticoagulants
- Contra-indication to treatment with Uvédose
- Moderate renal impairment.
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