Add-on fenfluramine in Lennox Gastaut epilepsy

Phase 1

• Conditions: ennox Gastaut Epilepsy; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-004008-46-BE
• Lead Sponsor: Z Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-26
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Electro-clinical epilepsy syndrome compatible with Lennox Gastaut syndrome
Minimum requirements (based on ILAE epilepsydiagnosis.org)
- multiple seizure types including in any case tonic seizures
- EEG shows slow spike waves and abnormal background
- abnormal cognitive development
- MRI compatible with Lennox Gastaut epilepsy : no progressive disease
- Drug resistant :
- at least 4 documented seizures in the last 4 weeks before inclusion
(minimum 4 seizures in at least 2 separate weeks)
Seizure types eligible for inclusion are : generalized tonic-clonic seizures GTC , tonic seizures TS , atonic seizures AS or clearly recognizable focal seizures FS.
- on >= 2 AEDs (including VNS) during the 4 weeks before inclusion
(no changes in treatment before inclusion and during the trial)
- Age between 3 and 18 years

Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Known clinical cardiovascular abnormalities (including valvular problems, shunts, pulmonary hypertension, exercise intolerance)
- Any cardiac ultrasound/ECG abnormalities at baseline
- Weight below percentile 3 for age at baseline

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified