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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

NCT02286817 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-10-21

No results posted yet for this 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).

Conditions

  • Attention-deficit Hyperactivity Disorder (ADHD)

Interventions

DRUG

NFC-1

Single-dose, open label administration to assess safety, tolerability, and pharmacokinetics in adolescents with ADHD and continuous daily administration for four weeks with weekly escalation to evaluate safety, tolerability, and impact on ADHD severity.

Sponsors & Collaborators

  • Thomas Jefferson University

    collaborator OTHER

  • Children's Hospital of Philadelphia

    collaborator OTHER

  • Pearson/Clinical Assessment

    collaborator INDUSTRY

  • Aevi Genomic Medicine, LLC, a Cerecor company

    lead INDUSTRY

Principal Investigators

  • Walter Kraft, MD · Thomas Jefferson University

  • Josephine Elia, MD · Alfred I. duPont Hospital for Children

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-05-31
Completion
2016-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02286817 on ClinicalTrials.gov