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

NCT02655198 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2023-09-22

No results posted yet for this study

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

DRUG

Fenfluramine

study 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).

Sponsors & Collaborators

  • Zogenix, Inc.

    collaborator INDUSTRY

  • KU Leuven

    lead OTHER

Principal Investigators

  • Lieven G Lagae, MD, PhD · Katolieke Universiteit Leuven, University Hospitals Gasthuisberg

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2018-09-30
Completion
2024-12-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02655198 on ClinicalTrials.gov