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

Overview

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

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

Interventions

Eligibility

Locations (5)

Outcomes