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

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

Study Overview

• Status: Terminated
• Conditions: ADHD
• Intervention / Treatment: Drug: NRCT-101SR, NRCT-202XR

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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Maitland, Florida, United States, 32751
      • Accel Research Site-Maitland Clinical Research Unit
  • Georgia
    • Decatur, Georgia, United States, 30030
      • iResearch Atlanta
    • Savannah, Georgia, United States, 31405
      • CenExel iRS - iResearch Savannah
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials Llc
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Center For Psychiatry And Behavioral Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

1. Male or female, 13-17 years of age at screening.
2. Has a prior primary diagnosis of ADHD according to the DSM-5 classification evident by a medical record and confirmed with MINI using DSM-5 probes.
3. Is taking ADHD medication 4-7 days/week, for at least 4 weeks at Screening and at least 6 weeks at Baseline.
4. Has side effects identified using SDSE-RS at Screening and Baseline.
5. CGI-S ≥ X (blinded) at Screening and Baseline.
6. Must be fluent in English and communicate effectively with others.
7. Both subject and parent/guardian willing and able to give informed assent/consent.
8. Parent/guardian willing to serve as informant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1; NRCT-101SR and low dose NRCT-202XR	Drug: NRCT-101SR, NRCT-202XR; NRCT-101SR in combination with NRCT-202XR or NRCT-202XR alone
Active Comparator: Arm 2; NRCT-101SR placebo and high dose NRCT-202XR	Drug: NRCT-101SR, NRCT-202XR; NRCT-101SR in combination with NRCT-202XR or NRCT-202XR alone
Active Comparator: Arm 3; NRCT-101SR placebo and low dose NRCT-202XR	Drug: NRCT-101SR, NRCT-202XR; NRCT-101SR in combination with NRCT-202XR or NRCT-202XR alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
CGI-S	6 weeks
SDSE-RS	6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Neurocentria, Inc.
• Investigators: Study Director: Guy Bar-Klein, PhD, Neurocentria, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2025
• Primary Completion (Actual): July 15, 2025
• Study Completion (Actual): July 15, 2025

Study Registration Dates

• First Submitted: November 1, 2024
• First Submitted That Met QC Criteria: November 1, 2024
• First Posted (Actual): November 4, 2024

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: NC-022A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No