NCT03609619

PART B: Efficacy and Safety of AEVI-001 in Children and Adolescents With ADHD and Without mGluR Mutations

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Aevi Genomic Medicine, LLC, a Cerecor company · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	AEVI-001	Oral doses of 100 mg, 200 mg or 400 mg of AEVI-001 will be administered twice daily, during the treatment period.
DRUG	Placebo	Oral doses of Placebo will be administered twice daily, during the treatment period.

Timeline

• Start date: 2018-08-17
• Primary completion: 2018-11-23
• Completion: 2018-11-30
• First posted: 2018-08-01
• Last updated: 2021-07-30
• Results posted: 2019-07-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study