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

NCT06673368 | Terminated Phase 2 FDA Drug

• 1 other identifier: NC-022A
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

ADHD

Outcome Measures

Primary Outcomes (2)

• CGI-S

  6 weeks

• SDSE-RS

  6 weeks

Secondary Outcomes (3)

• CBRS-P

  6 weeks

• DPREMB-R

  6 weeks

• ADHD-RS-5

  6 weeks

Study Arms (3)

Arm 1

ACTIVE COMPARATOR

NRCT-101SR and low dose NRCT-202XR

Drug: NRCT-101SR, NRCT-202XR

Arm 2

ACTIVE COMPARATOR

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

Drug: NRCT-101SR, NRCT-202XR

Arm 3

ACTIVE COMPARATOR

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

Drug: NRCT-101SR, NRCT-202XR

Interventions

NRCT-101SR, NRCT-202XR DRUG

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

Arm 1; Arm 2; Arm 3

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Neurocentria, Inc.: lead

Study Sites (5)

Accel Research Site-Maitland Clinical Research Unit

Maitland, Florida, 32751, United States

Location

iResearch Atlanta

Decatur, Georgia, 30030, United States

Location

CenExel iRS - iResearch Savannah

Savannah, Georgia, 31405, United States

Location

Boston Clinical Trials LLC

Boston, Massachusetts, 02131, United States

Location

Center For Psychiatry and Behavioral Medicine

Las Vegas, Nevada, 89128, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Guy Bar-Klein, PhD

  Neurocentria, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 4, 2024
• Study Start: February 25, 2025
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2025
• Last Updated: January 15, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)