Add-on Therapy With Low Dose Fenfluramine in Lennox Gastaut Epilepsy
Phase 2
Active, not recruiting
- Conditions
- Lennox Gastaut SyndromeEpilepsy
- Interventions
- Registration Number
- NCT02655198
- Lead Sponsor
- KU Leuven
- Brief Summary
In this trial, the potential anti-epileptic effect of low dose fenfluramine in Lennox Gastaut epilepsy will be studied. An exploratory dose finding add-on trial is proposed. At baseline and at the end of the study, ECG and ultrasound of the heart will be performed as part of the safety follow up.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 13
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description fenfluramine Fenfluramine Experimental : one armed open label study : Add-on fenfluramine in refractory Lennox Gastaut patients. Starting dose 0.2mg/kg/day. In non-responders (\<50% seizure frequency decrease), dose will be uptitrated every 4 weeks from 0,2 to 0,4 and max 0,8 mg/kg/day (max 30 mg). Total duration study and max exposure to the drug 20 weeks
- Primary Outcome Measures
Name Time Method Efficacy of add-on FFA in Lennox Gastaut epilepsy: Number of responders and seizure free patients at each FFA dosage (0,2 or 0,4 or 0,8 mg/kg/day) up to 20 weeks
- Secondary Outcome Measures
Name Time Method Seizure frequency change per patient and per major seizure type (Tonic Clonic Seizures (TCS), Tonic Seizures (TS), Atonic Seizures (AS), Focal Seizures (FS)) 20 weeks Adverse events (cardiac and general) 20 weeks Sleep quality : 10 point scale instrument to score sleep quality 20 weeks CGI (clinical global impression) scale at last visit , by patient/caregiver and treating physician 20 weeks
Trial Locations
- Locations (1)
University Hospitals UZ Leuven
🇧🇪Leuven, Belgium