Study to Evaluate NRCT-101SR in Pediatric Subjects With ADHD

NCT06215144 | Terminated Phase 2 FDA Drug

• 1 other identifier: NC-021B
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 13

Brief Summary

To evaluate the efficacy and safety of NRCT-101SR compared to placebo in subjects 13-17 years of age with ADHD

Conditions

Attention-Deficit/Hyperactivity Disorder (ADHD)

Outcome Measures

Primary Outcomes (1)

• Core Symptoms/ADHD Rating Scale (ADHD-RS-5)

  The ADHD-RS-5 consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with a total score ranging from 0 to 54. Each item has multiple prompts; the highest score that is generated from each prompt should be used as the score for that item. Evaluations will be based on symptoms over the week prior to the administration.

  over 12 weeks

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Up to 2,250 mg/day

Drug: NRCT-101SR

Control Arm

PLACEBO COMPARATOR

Matching placebo

Drug: NRCT-101SR

Interventions

NRCT-101SR DRUG

NRCT-101SR is a sustained release formulation.

Also known as: Matching Placebo

Control Arm; Experimental Arm

Eligibility Criteria

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

You may qualify if:

• Male or female, 13-17 years of age at screening.
• Has a primary diagnosis of ADHD according to the DSM-5 classification, confirmed with MINI using DSM-5 probes.
• ADHD-related symptoms - ADHD-RS-5 ≥ 28 in screening and baseline.
• \* Baseline score must not change by more than 25% from screening to baseline, except subjects who stop taking ADHD medication after screening may have an increase of more than 25%.
• Has a minimum score of 5 on the CGI-S at baseline.

You may not qualify if:

• Subject is functioning below an age-appropriate level intellectually, as judged by the Investigator.
• Lifetime history of severe psychiatric symptoms of major depression requiring hospitalization, bipolar disorder, schizophrenia or schizoaffective disorder, hallucinations, or delusions. Severe comorbid disorders such as PTSD, severe obsessive-compulsive disorder, or other symptomatic presentation that, in the opinion of the examining physician, will contraindicate NRCT-101SR treatment or confound efficacy or safety assessments. Subjects with mild to moderate forms of social phobia or dysthymia, for instance, may be included.
• History of seizures (other than infantile febrile seizures), any tic disorder (except transient tic disorder and subject has no episodes for at least 1 year), or a current diagnosis of Tourette's Disorder.
• Recent history (within the past 1 year) of suspected substance abuse or dependence disorder in accordance with DSM-5 criteria.
• Current abnormal thyroid function as defined as abnormal screening thyroid stimulating hormone. Treatment for at least 3 months with a stable dose of thyroid medication is permitted.
• History of poor kidney function; corrected estimated glomerular filtration rate (eGFR) \< 90 mL/min/m2
• History of significant gastrointestinal disorders, such as chronic diarrhea, irritable bowel syndrome, ulcerative colitis, Crohn's disease, etc.
• \*A woman is considered fertile following menarche unless permanently sterile; a premenarchal female is not considered a WOBCP).
• A "yes" answer to "suicidal ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at screening (in the past 12 months).
• Has history of severe drug allergy or hypersensitivity to the study medication or its excipients.
• Hypermagnesemia; serum magnesium \> 2.5 mg/dL.
• Hepatic impairment as defined by serum AST, ALT and/or ALP \> 1.25 ULN, and/or serum bilirubin \> 1.5 ULN.
• Known history of hepatitis B and/or C.:
• Is currently participating in another clinical trial or has participated in a clinical trial within 30 days or 5 half-lives of the investigational drug, whichever is longer, prior to the Screening Visit.
• Currently living in an institutional facility.

Sponsors & Collaborators

• Neurocentria, Inc.: lead

Study Sites (13)

Advanced Research Center, Inc

Anaheim, California, 92805, United States

Location

Accel Research Sites - Lakeland Clinical Research Unit

Lakeland, Florida, 33803, United States

Location

Accel Research Sites Network - Maitland

Maitland, Florida, 32751, United States

Location

Bio-Medical Research LLC

Miami, Florida, 33144, United States

Location

CenExel ACMR Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

iResearch Atlanta

Decatur, Georgia, 30030, United States

Location

CenExel iRS - iResearch Savannah

Savannah, Georgia, 31405, United States

Location

DelRicht Research

New Orleans, Louisiana, 70155, United States

Location

DelRicht Research

Prairieville, Louisiana, 70769, United States

Location

Boston Clinical Trials Llc

Boston, Massachusetts, 02131, United States

Location

Vector Clinical Trials

Las Vegas, Nevada, 89128, United States

Location

Coastal Carolina Research Center - North Charleston

North Charleston, South Carolina, 29405, United States

Location

Epic Medical Research - DeSoto

DeSoto, Texas, 75115, 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

• Guosong Liu, MD, 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: Double Blind placebo controlled

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 22, 2024
• Study Start: January 25, 2024
• Primary Completion: October 10, 2025
• Study Completion: November 6, 2025
• Last Updated: January 15, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)