NCT02348073

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

Efficacy of Phosphatidylserine Enriched With Polyunsaturated n-3 Fatty Acid Supplementation on Attention Deficit Disorders in Children With Epilepsy. A Randomized Double-blind Placebo-controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 6 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Attention Deficit Disorder With Hyperactivity
• ADHD Inattention or Mixed Type
• Epilepsy
• Child

Interventions

Type	Name	Description
DRUG	Vayarin®, supplementation of n-3 PUFA	Two capsules will be swallowed twice daily, 20 to 30 minutes prior to breakfast and dinner, during 12 weeks, between visit 1 and visit 2. At the end of this period, active product will be continued, at the same dose, for a 12 week-open label period. All patients will be administered the active product.
DRUG	PLACEBO	Two capsules will be swallowed twice daily, 20 to 30 minutes prior to breakfast and dinner, during 12 weeks, between visit 1 and visit 2.

Timeline

• Start date: 2015-03-01
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2015-01-28
• Last updated: 2025-08-06

Locations

13 sites across 1 country: France