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

Last updated: March 7, 2025
Sponsor: Neurocentria, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Attention Deficit/hyperactivity Disorder (Adhd - Adults)

Williams Syndrome

Treatment

NRCT-101SR, NRCT-202XR

Clinical Study ID

NCT06673368
NC-022A
  • Ages 13-17
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

  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 Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: NRCT-101SR, NRCT-202XR
Phase: 2
Study Start date:
February 25, 2025
Estimated Completion Date:
November 30, 2025

Study 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.

Connect with a study center

  • Accel Research Site-Maitland Clinical Research Unit

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • iResearch Atlanta

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • iRresearch Atlanta

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • CenExel iRS - iResearch Savannah

    Savannah, Georgia 31405
    United States

    Active - Recruiting

  • Boston Clinical Trials LLC

    Boston, Massachusetts 02131
    United States

    Active - Recruiting

  • Center For Psychiatry and Behavioral Medicine

    Las Vegas, Nevada 89128
    United States

    Active - Recruiting

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