Efficacy of FLUOXETINE in children with drug-resistant, complex and rare epilepsy (FLUOXEPIL)

Prior treatment

• Patient with previous history of mania/hypomania.
• Concomitant use of monoamin oxidase inhibitor or metoprolol

Other illness

• Patient with a history of bleeding disorders.
• Patient having a known history of diabete(s).
• Patient with history or presenting any abnormality of renal, hepatic or cardiac function
• Patient with treated or untreated hypertension
• Patient having a score of 23 or more obtained with the Neurological Disorders Depression Inventory-Epilepsy for Youth scale or any suicidal idea
• Patient presenting contraindications to fluoxetine: hypersensitivity to fluoxetine and/or excipients

Lab values

• Patient with known QT prolongation.
• Patient presenting with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome

Other

• Patient participating to another clinical trial
• Patient not in capacity to consent and/or without legal representative present to receive the information and give consent for the patient’s participation
• Patient taking oral anticoagulants.
• Pregnant or breastfeeding women
• Patient under 20 kg at the screening visit
• Patient with limited French proficiency

• Signed and dated informed consent form by the two parents (or one, if single-parent family, as documented in the medical file).
• Patient for whom at least 4 treatments (anti-seizure medications) have been prescribed, alone or in combination, at appropriate dosage, without controlling the seizures.
• Patient exhibiting daytime seizures with loss consciousness and/or leading to falls, and/or cyanotic nocturnal seizures
• Patient presenting at least 3 seizures/months on average
• Less than five concomitant anti-seizure medications (ASMs) at time of inclusion
• Patient having a dose of ASMs which is stable for at least one week prior to screening.
• For girls of childbearing potential, willing to use a highly effective contraceptive method throughout the study and until 6 weeks after the end of the treatment.
• Patient with no indication or epilepsy surgery, contra-indication of the surgery or failure/refusal of epilepsy surgery
• Patient having the ability to take oral medication
• Patient who is a beneficiary of or affiliated to a social security scheme
• Documented willingness of both parents to comply with all study procedures for the duration of the study (or one if single-parent family)
• Child or adolescent aged of 8 – 17 years old.
• Child assent for his/her participation to the research
• Patient with rare / complex epilepsy: Developmental and Epileptic Encephalopathy, structural severe epilepsies, rare epileptic syndromes as defined by the International League Against Epilepsy
• Patient presenting drug-resistant focal or generalized epilepsy according to the ILAE definition.