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

PHASE3CompletedINTERVENTIONAL
Enrollment

77

Participants

Timeline

Start Date

March 31, 2015

Primary Completion Date

October 31, 2018

Study Completion Date

October 31, 2018

Conditions
Attention Deficit Disorder With HyperactivityADHD Inattention or Mixed TypeEpilepsyChild
Interventions
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.

Trial Locations (13)

Unknown

CHU de Amiens, Amiens

CHU d'Angers, Angers

Hôpital des Enfants - Pellegrin, Bordeaux

CHRU Lille, Lille

Hospices Civils de Lyon, Lyon

Hôpital de la Timone, Marseille

Hôpital Necker-Enfants malades, Paris

Hôpital Robert-Debré, Paris

CHU de Rennes, Rennes

Hôpital de Hautepierre, Strasbourg

CHU de Toulouse, Toulouse

CHU de Tours, Tours

Hôpital Brabois - Rue du Morvan, Vandœuvre-lès-Nancy

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER

NCT02348073 - Efficacy of Phosphatidylserine Enriched With n-3 PUFA Supplementation on ADHD in Children With Epilepsy | Biotech Hunter | Biotech Hunter