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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 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 206-participant average among 88 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state.

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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.

Interventions

  • DRUG Placebo
  • DRUG AEVI-001

Study Locations (1)

Pennsylvania

  • Aevi Genomic Medicine - Wayne

Trial Details

FieldValue
Enrollment Target 69 participants
Start Date 2017-08-28
Est. Completion 2018-10-01
Phase Phase 2

What the Registry Record Tells You About NCT03265119

The ClinicalTrials.gov registry entry for NCT03265119 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 206-participant average among 88 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (67% lower). 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 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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.