Efficacy of FLUOXETINE in children with drug-resistant, complex and rare epilepsy (FLUOXEPIL)
Key facts
- Where
- Bordeaux, Lyon Cedex 04, Marseille, Montpellier Cedex 5, Paris és Toulouse Cedex 9, FranciaországSee the 6 sites
- Phase
- 3. fázis
Where in Franciaország
- Pellegrin HospitalBordeaux, FranciaországToborzás még nem indult
- Hospital La Croix Rousse HclLyon Cedex 04, FranciaországToborzás még nem indult
- Institut Des Neurosciences De La TimoneMarseille, FranciaországToborzás még nem indult
- Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5, FranciaországToborzás még nem indult
- Robert Debre University HospitalParis, FranciaországToborzás még nem indult
- Centre Hospitalier Universitaire De ToulouseToulouse Cedex 9, FranciaországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre Hospitalier Regional De Marseille
- Trial code
- EU 2024-519897-38-01
- Record updated
- 2026. szeptember 15.
- Original description
To compare the efficacy of fluoxetine plus anti-seizure treatment as usual (TAU) versus placebo plus TAU in reducing the frequency of seizures in children of at least 8 years of age having drug-resistant epilepsy.Read full original descriptionShow less
Randomized double-blinded placebo-controlled study of the efficacy of fluoxetine in add-on treatment of drug-resistant, complex and rare epilepsy in children aged 8 years and older: use of a design evaluating the time to reach a defined number of seizures for each child during the prospective observational phase (FLUOXEPIL)
To compare the efficacy of fluoxetine plus anti-seizure treatment as usual (TAU) versus placebo plus TAU in reducing the frequency of seizures in children of at least 8 years of age having drug-resistant epilepsy.
Inclusion: 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.
Exclusion: Patient with previous history of mania/hypomania; Concomitant use of monoamin oxidase inhibitor or metoprolol; 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; Patient with known QT prolongation; Patient presenting with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome; 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.