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

Phase 2

Recruiting

• Conditions: ADHD
• Interventions: Drug: NRCT-101SR, NRCT-202XR

• Registration Number: NCT06673368
• Lead Sponsor: Neurocentria, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2024-11-01
• Study First Submitted QC: 2024-11-01
• Study First Posted: 2024-11-04
• Study Start: 2025-02-25
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-12
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	NRCT-101SR, NRCT-202XR	NRCT-101SR and low dose NRCT-202XR
Arm 2	NRCT-101SR, NRCT-202XR	NRCT-101SR placebo and high dose NRCT-202XR
Arm 3	NRCT-101SR, NRCT-202XR	NRCT-101SR placebo and low dose NRCT-202XR

Primary Outcome Measures

Name	Time	Method
CGI-S	6 weeks
SDSE-RS	6 weeks

Secondary Outcome Measures

Name	Time	Method
CBRS-P	6 weeks	and academic problems in children between the ages of 6 and 18 years and are reported by parents.
DPREMB-R	6 weeks
ADHD-RS-5	6 weeks

Trial Locations

Locations (5)

Accel Research Site-Maitland Clinical Research Unit; 🇺🇸 Maitland, Florida, United States

iResearch Atlanta; 🇺🇸 Decatur, Georgia, United States

CenExel iRS - iResearch Savannah; 🇺🇸 Savannah, Georgia, United States

Boston Clinical Trials LLC; 🇺🇸 Boston, Massachusetts, United States

Center For Psychiatry and Behavioral Medicine; 🇺🇸 Las Vegas, Nevada, United States