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ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, 2-Part, 6-Week, Double-blind, Randomized, Placebo-controlled, Parallel-design Study to Assess the Efficacy and Safety of AEVI-001 in Children and Adolescents (Ages 6-17 Years) With Attention Deficit Hyperactivity Disorder and With or Without Copy Number Variants in Specific Genes Implicated in Glutamatergic Signaling and Neuronal Connectivity
In Brief
A Phase 2 clinical trial evaluating AEVI-001 and Placebo for Attention Deficit Hyperactivity Disorder. Completed, enrolled 109 participants across 1 site.
Detailed Summary
This is PART B of a 2-part, 6-week, double-blind, dose-optimization, parallel-group study in children and adolescents (ages 6-17 years) with ADHD with and without CNVs in specific genes implicated in glutamatergic signaling and neuronal activity. PART B will assess subjects who do not have CNVs in any of the specific gene mutation(s) implicated in glutamatergic signaling and neuronal connectivity.
Study Details
Timeline
Interventions
Oral doses of 100 mg, 200 mg or 400 mg of AEVI-001 will be administered twice daily, during the treatment period.
Oral doses of Placebo will be administered twice daily, during the treatment period.