NCT03265119

PART A: Efficacy and Safety of AEVI-001 in Children and Adolescents With ADHD and With 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: 69 (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 A 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. Parts A will include subjects determined to have a specific gene mutations 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 100 mg, 200 mg or 400 mg of Placebo will be administered twice daily during the treatment period.

Timeline

• Start date: 2017-08-28
• Primary completion: 2018-09-24
• Completion: 2018-10-01
• First posted: 2017-08-29
• Last updated: 2021-07-07
• Results posted: 2019-07-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study