NCT06673368

A Phase 2 Randomized Double-Blind, Parallel, Adaptive-Design, Clinical Trial to Evaluate the Safety and Efficacy of NRCT-101SR With NRCT-202XR Compared to NRCT-202XR Alone in Subjects With Attention-Deficit/Hyperactivity Disorder

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

Summary

A combination therapy of NRCT-101 with NRCT-202 is being developed for patients with ADHD.

Detailed description

A multi-center, randomized, double-blind, parallel, adaptive-design clinical trial to evaluate the safety and efficacy of co-administration of NRCT-101SR and low dose NRCT- 202XR compared to low or high dose of NRCT-202XR and placebo NRCT-101SR over a 6-week period in approximately 60 pediatric subjects (13-17 years of age) with ADHD. Subjects' enrollment will be conducted in two stages. In stage 1, subjects are planned to be randomized to one of the following two arms (1:1 ratio): Arm 1: NRCT-101SR and low dose NRCT-202XR Arm 2: NRCT-101SR placebo and high dose NRCT-202XR In stage 2, a third study arm will be added (Arm 3 - NRCT-101SR placebo and low dose NRCT-202XR. The study population will include male and female subjects (sex assigned at birth) of all races/ethnicities with ADHD.

Conditions

• ADHD

Interventions

Type	Name	Description
DRUG	NRCT-101SR, NRCT-202XR	NRCT-101SR in combination with NRCT-202XR or NRCT-202XR alone

Timeline

• Start date: 2025-02-25
• Primary completion: 2025-07-15
• Completion: 2025-07-15
• First posted: 2024-11-04
• Last updated: 2026-01-15

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study