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: 21.0 Level: PT Classification code 10015037 Term: Epilepsy System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: fenfluramine
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: FENFLURAMINE
CAS Number: 458-24-2
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: range
Concentra
Sponsors
University Hospital Antwerp
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: cardiological abnormalities follow-up insure glaucoma medication treated hypertension allergic reaction on fenfluramine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 reducing the number of seizures;Timepoint(s) of evaluation of this end point: evalution every three months for maximum 10 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): possible ADR, maily cariological ;Timepoint(s) of evaluation of this end point: evalution every three months for maximum 10 years | — |
Countries
Belgium
Outcome results
None listed