Fenfluramine as anti-epilepticum in a difficult to treat epilepsy syndrome.
Phase 1
- Conditions
- Fenfluramine is an amphetamine which was in the past used as anorexigan. Their are a few publications of effectivness of this medication in epilepsy.We want to investigate was is the exact place of fenfluramine in the treatment of a therapy resitant epilepsy named Dravet syndrome.MedDRA version: 21.0Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2011-004114-42-BE
- Lead Sponsor
- niversity Hospital Antwerp
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
age: 1-50y
Dravet syndrome
therapyresistent epilepsy
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 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
cardiological abnormalities
follow-up insure
glaucoma
medication treated hypertension
allergic reaction on fenfluramine
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: We want to investigate the effectivness of fenfluramine in a group of patients with Dravet syndrome.;Secondary Objective: We want to investigate the effectivness of fenfluramine in a group of patients with Dravet syndrome.;Primary end point(s): seizure freedom or <br>reducing the number of seizures;Timepoint(s) of evaluation of this end point: evalution every three months for maximum 10 years
- Secondary Outcome Measures
Name Time Method Secondary end point(s): possible ADR, maily cariological ;Timepoint(s) of evaluation of this end point: evalution every three months for maximum 10 years