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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 is a Phase 2 study that has completed, run by Aevi Genomic Medicine, LLC, a Cerecor company. The registered enrollment target is 109 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03609619
The ClinicalTrials.gov registry entry for NCT03609619 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 109 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Aevi Genomic Medicine, LLC, a Cerecor company, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03609619 reports 0 study locations.
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.
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