Add-on Therapy With Low Dose Fenfluramine in Lennox Gastaut Epilepsy (NCT02655198) | Clinical Trial Compass
UnknownPhase 2
Add-on Therapy With Low Dose Fenfluramine in Lennox Gastaut Epilepsy
Belgium13 participantsStarted 2016-01
Plain-language 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.
Who can participate
Age range3 Years – 18 Years
SexALL
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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
* Subject is male or non-pregnant, non-lactating female. Female subjects of childbearing potential must not be pregnant or breast-feeding. Female subjects of childbearing potential must have a negative urine pregnancy test. Subjects of childbearing or child-fathering potential must be willing to use medically acceptable forms of birth control, which includes abstinence, while being treated on this study and for 90 days after the last dose of study drug.
Exclusion Criteria
* Known clinical cardiovascular abnormalities (including valvular problems, shunts, pulmonary hypertension, exercise intolerance)
* Any cardiac ultrasound/ECG abnorm…
What they're measuring
1
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)