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NCT03265119 · ClinicalTrials.gov registry record · Phase 2
PART A: Efficacy and Safety of AEVI-001 in Children and Adolescents With ADHD and With mGluR Mutations
A Phase 2 study of Attention Deficit Hyperactivity Disorder, sponsored by Aevi Genomic Medicine, LLC, a Cerecor company.
- Completed
- Registry status
- Phase 2
- Development phase
- 69
- Enrollment target
- 1
- Study location
NCT03265119: Completed Phase 2 study of Attention Deficit Hyperactivity Disorder, sponsored by Aevi Genomic Medicine, LLC, a Cerecor company.
NCT03265119 is a Phase 2 study of Attention Deficit Hyperactivity Disorder that has completed, run by Aevi Genomic Medicine, LLC, a Cerecor company. The registered enrollment target is 69 participants, below the 216-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03265119, a Phase 2 study of Attention Deficit Hyperactivity Disorder, has completed, sponsored by Aevi Genomic Medicine, LLC, a Cerecor company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 69 participants
- Enrollment target
- 1
- Study location
Study 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.
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG AEVI-001
Study Locations (1)
Pennsylvania
- Aevi Genomic Medicine - Wayne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2017-08-28 |
| Est. Completion | 2018-10-01 |
| Phase | Phase 2 |
What the finished NCT03265119 record still lists
NCT03265119 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 216-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (68% lower).
The record links to 1 condition, with Attention Deficit Hyperactivity Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03265119 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03265119 about?
NCT03265119 is a clinical study titled "PART A: Efficacy and Safety of AEVI-001 in Children and Adolescents With ADHD and With mGluR Mutations". 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 sp...
What is the current status of trial NCT03265119?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2017-08-28. Estimated completion is 2018-10-01.
What conditions does trial NCT03265119 study?
This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder.
What interventions are being tested in trial NCT03265119?
The interventions under investigation include: Placebo (DRUG), AEVI-001 (DRUG).
Who is sponsoring clinical trial NCT03265119?
This trial is sponsored by Aevi Genomic Medicine, LLC, a Cerecor company, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03265119 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03265119's enrollment target sits among peer trials
69 54th of 102 higher than 49 of 102 other Attention Deficit Hyperactivity Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Attention Deficit Hyperactivity Disorder 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.
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