NCT06215144

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

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

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Neurocentria, Inc. · Industry
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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 12-week period in approximately 160 pediatric subjects (13-17 years of age) with ADHD. Selected sites will collect blood samples for PK from a subset of subjects. The primary endpoint of the study is ADHD Rating Scale (ADHD-RS). The primary analysis will be on effects of 12-week treatment of NRCT-101SR versus placebo on ADHD-RS in subjects with ADHD.

Conditions

• Attention-Deficit/Hyperactivity Disorder (ADHD)

Interventions

Type	Name	Description
DRUG	NRCT-101SR	NRCT-101SR is a sustained release formulation.

Timeline

• Start date: 2024-01-25
• Primary completion: 2025-10-10
• Completion: 2025-11-06
• First posted: 2024-01-22
• Last updated: 2026-01-15

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study