Clinical Trials Directory

Trials / Unknown

UnknownNCT02655198

Add-on Therapy With Low Dose Fenfluramine in Lennox Gastaut Epilepsy

Status
Unknown
Phase
Phase 2
Study type
Interventional
Enrollment
13 (actual)
Sponsor
KU Leuven · Academic / Other
Sex
All
Age
3 Years – 18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGFenfluraminestudy of efficacy and safety of add-on fenfluramine at different dosages in refractory Lennox Gastaut patients : 0.2 - 0.4 and 0.8 mg/kg/day (max 30 mg).

Timeline

Start date
2016-01-01
Primary completion
2018-09-01
Completion
2024-12-01
First posted
2016-01-13
Last updated
2023-09-22

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT02655198. Inclusion in this directory is not an endorsement.