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)

Condition studied

complex and rare epilepsy in children aged 8 years and older

Investigational medicinal product(s)

Eligibility

Primary endpoint

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.

Endpoint detail

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.