Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-24 @ 6:29 PM
NCT ID:
NCT06673368
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:
NCT06673368
Study Brief:
Protocol Section:
NCT06673368