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ADHD Inattention or Mixed Type clinical trials

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NCT ID: NCT02348073 Completed - Epilepsy Clinical Trials

Efficacy of Phosphatidylserine Enriched With n-3 PUFA Supplementation on ADHD in Children With Epilepsy

AGPIn3
Start date: March 2015
Phase: Phase 3
Study type: Interventional

Our project aims to develop a new therapeutic approach in epilepsy-associated attention disorders in children, through evaluation of the clinical impact of dietary n-3 fatty acids, containing eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) conjugated to a phospholipid vector. The primary objective is to evaluate the efficacy of a PUFA supplementation (PS-Omega 3), after 12 weeks of treatment, on attention disorders in children with epilepsy. Secondary objectives include: - To evaluate the impact of a supplementation of PS-Omega 3 on quality of life. - To evaluate the impact of a supplementation of PS-Omega 3 on serum and erythrocyte lipid profiles. - To assess the tolerance of a supplementation of PS-Omega 3. - To assess the impact of a supplementation of PS-Omega 3 on the frequency of seizures. - To describe the impact of a supplementation of PS-Omega 3, at 24 weeks, 1. on attention disorders in children with epilepsy, 2. on quality of life, 3. and on serum and erythrocyte lipid profiles. This study will recruit 272 subjects aged 6- 16 years, suffering from epilepsy (any type) and attention deficit hyperactivity disorder (ADHD) (inattentive or combined type) according to DSM V criteria in 12 clinical sites in France.