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Study to Evaluate NRCT-101SR in Pediatric Subjects With ADHD — ADHD  

Attention-Deficit/Hyperactivity Disorder (ADHD) Clinical Trial

Official title:
A Phase 2/3 Randomized Double-Blind Placebo Controlled Clinical Trial to Evaluate the Safety and Efficacy of NRCT-101SR in Pediatric Subjects With Attention-Deficit/Hyperactivity Disorder

Clinical Trial Summary

To evaluate the efficacy and safety of NRCT-101SR compared to placebo in subjects 13-17 years of age with ADHD

Clinical Trial Description

a multi-center, randomized, double-blind, placebo-controlled, parallel-arm design, laboratory classroom (LC) clinical trial to evaluate the safety and efficacy of NRCT-101SR (up to to 2,000 mg/day based on LBM) over a 6-week period in approximately 160 pediatric subjects (13-17 years of age) with ADHD. An open label extension (OLE) of 6 weeks will be optional. Selected sites will collect blood samples for PK from a subset of subjects. The primary endpoint of the study is Permanent Product Measure of Performance (PERMP) Math Tests and the key secondary endpoint is ADHD Rating Scale (ADHD-RS). The primary analysis will be on effects of 6-week treatment of NRCT-101SR versus placebo on performance (PERMP) in subjects with ADHD. ;

Study Design

Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention-Deficit/Hyperactivity Disorder (ADHD)
  • Hyperkinesis
Clinical Trial Details
NCT number NCT06215144
Study type Interventional
Source Neurocentria, Inc.
Contact Mary Miller, MAOM
Phone 925-954-4868
Email mmiller@neurocentria.com
Status Recruiting
Phase Phase 2/Phase 3
Start date January 25, 2024
Completion date February 1, 2025
View Details
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