Clinical trial NCT06673368: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: ADHD
Lead sponsor: Neurocentria, Inc.
Sponsor class: INDUSTRY
First posted: 2024-11-04
Enrollment: 60
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multi-center, randomized, double-blind, parallel, adaptive-design clinical trial
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: CGI-S
timeFrame: 6 weeks
measure: SDSE-RS
timeFrame: 6 weeks
Secondary outcomes:
measure: CBRS-P
timeFrame: 6 weeks
measure: DPREMB-R
timeFrame: 6 weeks
measure: ADHD-RS-5
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Maitland
country: United States
facility: Accel Research Site-Maitland Clinical Research Unit
state: Florida
city: Decatur
country: United States
facility: iResearch Atlanta
state: Georgia
city: Savannah
country: United States
facility: CenExel iRS - iResearch Savannah
state: Georgia
city: Boston
country: United States
facility: Boston Clinical Trials LLC
state: Massachusetts
city: Las Vegas
country: United States
facility: Center For Psychiatry and Behavioral Medicine
state: Nevada
Study officials:
affiliation: Neurocentria, Inc.
name: Guy Bar-Klein, PhD
role: STUDY_DIRECTOR
References: