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

Neurocentria

Status and phase: Enrolling; Phase 2

Conditions: ADHD

Treatments: Drug: NRCT-101SR, NRCT-202XR

Study type: Interventional

Funder types: Industry

Identifiers

NCT06673368

NC-022A

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Arm 1

Active Comparator group

Description:

NRCT-101SR and low dose NRCT-202XR

Treatment:

Drug: NRCT-101SR, NRCT-202XR

Arm 2

Active Comparator group

Description:

NRCT-101SR placebo and high dose NRCT-202XR

Treatment:

Drug: NRCT-101SR, NRCT-202XR

Arm 3

Active Comparator group

Description:

NRCT-101SR placebo and low dose NRCT-202XR

Treatment:

Drug: NRCT-101SR, NRCT-202XR