Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT02286817 · ClinicalTrials.gov registry record · Phase 1

Phase I Single Dose, Open-Label Pharmacokinetic Study and Single-Blind, Placebo-Controlled Dose Escalation Study of NFC-1 in Adolescents With Attention-Deficit Hyperactivity Disorder

A Phase 1 study of Attention Deficit Hyperactivity Disorder (ADHD), sponsored by Aevi Genomic Medicine, LLC, a Cerecor company.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target
1
Study location

NCT02286817 is a Phase 1 study of Attention Deficit Hyperactivity Disorder (ADHD) that has completed, run by Aevi Genomic Medicine, LLC, a Cerecor company. The registered enrollment target is 30 participants, below the 146-participant average among 15 other Attention Deficit Hyperactivity Disorder (ADHD) trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT02286817, a Phase 1 study of Attention Deficit Hyperactivity Disorder (ADHD), has completed, sponsored by Aevi Genomic Medicine, LLC, a Cerecor company.

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target
1
Study location

Study Summary

This trial is a Phase 1 study in adolescents with ADHD and genetic disruptions impacting genes in the metabotropic glutamate receptor (mGluR) network. The objectives of the study are to evaluate the safety, tolerability, and pharmacokinetics following single-dose, oral administration of NFC-1 and to evaluate safety and tolerability and to obtain evidence for the effect of NFC-1 on ADHD severity and global functioning during and following four weeks of continuous treatment. Exploratory analyses will be performed to assess effect size of specific mGluR-network genes on ADHD based on responsiveness of patients to NFC-1. This study will be conducted at a single clinical site, the Jefferson University Hospital PKU (Philadelphia, PA).

Interventions

  • DRUG NFC-1

Study Locations (1)

Pennsylvania

  • Thomas Jefferson University, Clinical Research Unit - Philadelphia

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2015-01
Est. Completion 2016-03
Phase Phase 1

What the Registry Record Tells You About NCT02286817

The ClinicalTrials.gov registry entry for NCT02286817 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 146-participant average among 15 other Attention Deficit Hyperactivity Disorder (ADHD) trials with a reported enrollment target (79% 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 (ADHD) appearing as the primary indexed condition, and to 1 intervention - of which NFC-1 is the first listed.

NCT02286817 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT02286817 about?

NCT02286817 is a clinical study titled "Phase I Single Dose, Open-Label Pharmacokinetic Study and Single-Blind, Placebo-Controlled Dose Escalation Study of NFC-1 in Adolescents With Attention-Deficit Hyperactivity Disorder". This trial is a Phase 1 study in adolescents with ADHD and genetic disruptions impacting genes in the metabotropic glutamate receptor (mGluR) network. The objectives of the study are to evaluate the safety, tolerability, and pharmacokinetics following single-dose, oral administration of NFC-1 and to...

What is the current status of trial NCT02286817?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2015-01. Estimated completion is 2016-03.

What conditions does trial NCT02286817 study?

This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder (ADHD).

What interventions are being tested in trial NCT02286817?

The interventions under investigation include: NFC-1 (DRUG).

Who is sponsoring clinical trial NCT02286817?

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 NCT02286817 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Attention Deficit Hyperactivity Disorder (ADHD)

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

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.