drugset / Trial / NCT03609619

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

NCT03609619 ↗

Phase 2 Completed 109 enrolled Aevi Genomic Medicine, LLC, a Cerecor company
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2018-08-17
Primary completion
2018-11-23
Completion
2018-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject fasoracetam Small molecule 100 mg Oral
Subject fasoracetam Small molecule 200 mg Oral
Subject fasoracetam Small molecule 400 mg Oral