Status and phase
Conditions
Treatments
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion criteria
Electro-clinical epilepsy syndrome compatible with Lennox Gastaut syndrome:
Minimum requirements (based on ILAE epilepsydiagnosis.org):
Drug resistant:
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
Primary purpose
Allocation
Interventional model
Masking
13 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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