Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-24 @ 6:29 PM
Study NCT ID:
NCT06673368
Status:
RECRUITING
Last Update Posted:
2025-03-12
First Post:
2024-11-01
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Neurocentria, Inc.
Organization:
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: