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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.
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).
Conditions Studied
Interventions
- DRUG NFC-1
Study Locations (1)
Pennsylvania
- Thomas Jefferson University, Clinical Research Unit - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2015-01 |
| Est. Completion | 2016-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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