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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-25

Study Completion Date

2025-07-15

Brief Summary

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

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Detailed Description

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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

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ADHD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A multi-center, randomized, double-blind, parallel, adaptive-design clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm 1

NRCT-101SR and low dose NRCT-202XR

Group Type ACTIVE_COMPARATOR

NRCT-101SR, NRCT-202XR

Intervention Type DRUG

NRCT-101SR in combination with NRCT-202XR or NRCT-202XR alone

Arm 2

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

Group Type ACTIVE_COMPARATOR

NRCT-101SR, NRCT-202XR

Intervention Type DRUG

NRCT-101SR in combination with NRCT-202XR or NRCT-202XR alone

Arm 3

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

Group Type ACTIVE_COMPARATOR

NRCT-101SR, NRCT-202XR

Intervention Type DRUG

NRCT-101SR in combination with NRCT-202XR or NRCT-202XR alone

Interventions

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NRCT-101SR, NRCT-202XR

NRCT-101SR in combination with NRCT-202XR or NRCT-202XR alone

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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.

Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No