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NCT03609619 · ClinicalTrials.gov registry record · Phase 2
PART B: Efficacy and Safety of AEVI-001 in Children and Adolescents With ADHD and Without mGluR Mutations
A Phase 2 study, sponsored by Aevi Genomic Medicine, LLC, a Cerecor company.
- Completed
- Registry status
- Phase 2
- Development phase
- 109
- Enrollment target
NCT03609619: Completed Phase 2 study, sponsored by Aevi Genomic Medicine, LLC, a Cerecor company.
NCT03609619 is a Phase 2 study that has completed, run by Aevi Genomic Medicine, LLC, a Cerecor company. The registered enrollment target is 109 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03609619, a Phase 2 study, has completed, sponsored by Aevi Genomic Medicine, LLC, a Cerecor company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 109 participants
- Enrollment target
Study 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.
Primary Outcome
The ADHD-RS-5 is comprised of 18 frequency items and 12 impairment items. Each frequency item was scored on a scale from 0 = "Never or rarely" to 3 = "Very often". The ADHD-RS-5 total score was calculated as the sum of the 18 frequency item scores. The total score ranges from 0 to 54. Higher scores indicate greater symptom severity. Change from baseline value were calculated as the assessment value minus the baseline value.
Interventions
- DRUG Placebo
- DRUG AEVI-001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2018-08-17 |
| Est. Completion | 2018-11-30 |
| Phase | Phase 2 |
What the finished NCT03609619 record still lists
NCT03609619 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (18% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03609619 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03609619 about?
NCT03609619 is a clinical study titled "PART B: Efficacy and Safety of AEVI-001 in Children and Adolescents With ADHD and Without mGluR Mutations". 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 a...
What is the current status of trial NCT03609619?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 109 participants. The study started on 2018-08-17. Estimated completion is 2018-11-30.
What interventions are being tested in trial NCT03609619?
The interventions under investigation include: Placebo (DRUG), AEVI-001 (DRUG).
Who is sponsoring clinical trial NCT03609619?
This trial is sponsored by Aevi Genomic Medicine, LLC, a Cerecor company, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03609619's enrollment target sits among peer trials
109 640th of 2000 higher than 1,361 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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