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

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

January 31, 2015

Primary Completion Date

May 31, 2015

Study Completion Date

March 31, 2016

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.

Trial Locations (1)

19107

Thomas Jefferson University, Clinical Research Unit, Philadelphia

All Listed Sponsors
collaborator

Thomas Jefferson University

OTHER

collaborator

Children's Hospital of Philadelphia

OTHER

collaborator

Pearson/Clinical Assessment

INDUSTRY

lead

Aevi Genomic Medicine, LLC, a Cerecor company

INDUSTRY

NCT02286817 - 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 | Biotech Hunter | Biotech Hunter