Overview
A combination therapy of NRCT-101 with NRCT-202 is being developed for patients with ADHD.
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.
Eligibility
- Male or female, 13-17 years of age at screening.
- 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.
- Is taking ADHD medication 4-7 days/week, for at least 4 weeks at Screening and at
least 6 weeks at Baseline.
- Has side effects identified using SDSE-RS at Screening and Baseline.
- CGI-S ≥ X (blinded) at Screening and Baseline.
- Must be fluent in English and communicate effectively with others.
- Both subject and parent/guardian willing and able to give informed assent/consent.
- Parent/guardian willing to serve as informant.