2024-519897-38-01招募中3 期
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)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- The number of observation-periods elapsed from end of study drug titration to the occurrence of a number of “N” seizures in fluoxetine plus treatment as usual versus placebo plus treatment as usual, where N is the individualized number of seizures observed during baseline will be assessed.
研究概览
简要总结
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.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 with known QT prolongation.
- •Patient with previous history of mania/hypomania.
- •Patient taking oral anticoagulants.
- •Patient with a history of bleeding disorders.
- •Patient having a known history of diabete(s).
- •Patient presenting with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome
- •Pregnant or breastfeeding women
- •Patient under 20 kg at the screening visit
- •Concomitant use of monoamin oxidase inhibitor or metoprolol
- •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 limited French proficiency
结局指标
主要结局
The number of observation-periods elapsed from end of study drug titration to the occurrence of a number of “N” seizures in fluoxetine plus treatment as usual versus placebo plus treatment as usual, where N is the individualized number of seizures observed during baseline will be assessed.
The number of observation-periods elapsed from end of study drug titration to the occurrence of a number of “N” seizures in fluoxetine plus treatment as usual versus placebo plus treatment as usual, where N is the individualized number of seizures observed during baseline will be assessed.
次要结局
- The proportion of patients with 0 seizure during the maintenance periods (16 weeks of maintenance maximum)
- The impact on behavior will be evaluated by the change in child behavior checklist score
- Number and nature of adverse events and effects
- Fluoxetine trough levels will be measured at the end of titration period, visit 1 and end of study visit
- The impact on behavior will be evaluated by the change in Child Behavior CheckList (CBCL).
- Proportion of patients with seizure exacerbation (greater intensity) and proportion of patients with new seizure type between baseline and follow-up.
- Frequency percent change in total seizures and in different seizure types.
研究者
Pr Mathieu Milh
Scientific
Centre Hospitalier Regional De Marseille
研究点 (6)
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