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Vayarin for ADHD in Children With Epilepsy
NCT02348073Phase 3
Key facts
- Status
- Completed
- Start
- Mar 2015
- Primary completion
- Oct 2018
- Countries
- 1
- Sponsor
- Hospices Civils de Lyon
- Modality
- Small Molecules
- Conditions
- attention deficit hyperactivity disorder (ADHD)
01
Overview
Phase 3, randomised, double-blind trial of omega-3-acid triglycerides in attention deficit hyperactivity disorder (ADHD) (2 arms), sponsored by Hospices Civils de Lyon. Primary endpoint: ADHD Rating Scale IV Inattentive Subscore at 12 weeks. Started Mar 2015; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
PS-OMEGA 3
Vayarin capsules twice daily
PLACEBO
Placebo capsules twice daily
03
Who it enrols
Children aged 6-15 with epilepsy on stable antiepileptic drugs and ADHD (inattentive or mixed type), excluding those with exclusive hyperactivity, mental retardation, other psychiatric comorbidities, diabetes, or recent use of psychoactive drugs for ADHD.
04
Endpoints
Primary
ADHD Rating Scale IV Inattentive Subscore
Secondary
ADHD Rating Scale IV Total Score
Test of Variables of Attention Total Score
Proportion of Subjects with a Normalized TOVA Score
Quality of Life Score
Plasma Lipid Profiles
Erythrocyte Lipid Profiles
Tolerance of Supplementation
Reduction in Frequency of Seizures >= 50%
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