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

Last updated: March 7, 2025
Sponsor: Neurocentria, Inc.
Overall Status: Active - Recruiting

Phase

2/3

Condition

Attention Deficit/hyperactivity Disorder (Adhd - Adults)

Williams Syndrome

Treatment

NRCT-101SR

Clinical Study ID

NCT06215144
NC-021B
  • Ages 13-17
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female, 13-17 years of age at screening.

  2. Has a primary diagnosis of ADHD according to the DSM-5 classification, confirmedwith MINI using DSM-5 probes.

  3. ADHD-related symptoms - ADHD-RS-5 ≥ 26 in screening and baseline.

  • Baseline score must not change by more than 25% from screening to baseline, exceptsubjects who stop taking ADHD medication after screening may have an increase ofmore than 25%.
  1. Has a minimum score of 4 on the CGI-S at baseline.

Exclusion

Exclusion Criteria:

  1. PERMP-C score > 200 in Moderate difficulty level in orientation.

  2. PERMP-C score > 180 in Easy difficulty level AND < 80 in Moderate difficulty levelin orientation.

  3. Subject is functioning below an age-appropriate level intellectually, as judged bythe Investigator.

  4. Lifetime history of severe psychiatric symptoms of major depression requiringhospitalization, bipolar disorder, schizophrenia or schizoaffective disorder,hallucinations, or delusions. Severe comorbid disorders such as PTSD, severeobsessive-compulsive disorder, or other symptomatic presentation that, in theopinion of the examining physician, will contraindicate NRCT-101SR treatment orconfound efficacy or safety assessments. Subjects with mild to moderate forms ofsocial phobia or dysthymia, for instance, may be included.

  5. 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), ora current diagnosis of Tourette's Disorder.

  6. Recent history (within the past 1 year) of suspected substance abuse or dependencedisorder in accordance with DSM-5 criteria.

  7. Current abnormal thyroid function as defined as abnormal screening thyroidstimulating hormone. Treatment for at least 3 months with a stable dose of thyroidmedication is permitted.

  8. History of poor kidney function; corrected estimated glomerular filtration rate (eGFR) < 90 mL/min/m2

  9. History of significant gastrointestinal disorders, such as chronic diarrhea,irritable bowel syndrome, ulcerative colitis, Crohn's disease, etc.

  10. Female subjects who are pregnant and/or lactating and/or sexually active women ofchildbearing potential (WOCBP) not agreeing to use birth control methods outlined ininclusion criterion.

  11. *A woman is considered fertile following menarche unless permanently sterile; apremenarchal female is not considered a WOBCP).

  12. A "yes" answer to "suicidal ideation" item 4 (active suicidal ideation with someintent to act, without specific plan) or item 5 (active suicidal ideation withspecific plan and intent) on the C-SSRS assessment at screening (in the past 12months).

  13. Has history of severe drug allergy or hypersensitivity to the study medication orits excipients.

  14. Hypermagnesemia; serum magnesium > 2.5 mg/dL.

  15. Hepatic impairment as defined by serum AST, ALT and/or ALP > 1.25 ULN, and/or serumbilirubin > 1.5 ULN.

  16. Known history of hepatitis B and/or C.:

  17. Is currently participating in another clinical trial or has participated in aclinical trial within 30 days or 5 half-lives of the investigational drug, whicheveris longer, prior

  18. to the Screening Visit.

  19. Currently living in an institutional facility.

  20. Severe physical disability not associated with cognitive function that limitsability to complete testing.

  21. Known history of symptomatic cardiac disease, advanced atherosclerosis, structuralcardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronaryheart disease, transient ischemic attack or stroke or other serious cardiacproblems.

  22. Known family history of sudden cardiac death or ventricular arrhythmia.

  23. Serious or unstable clinically important systemic illness or disease that, in thejudgment of the Investigator, is likely to affect the study assessments,deteriorate, or affect the subject's safety or ability to complete the study,including hepatic (e.g., Child-Pugh grade C), renal, gastroenterological,respiratory, cardiovascular, endocrinologic, immunologic, infectious, or hematologicdisorders.

  24. Has previously participated in a NRCT-101SR / L-TAMS investigational study.

  25. Investigators and their immediate family members are not permitted to participate inthe study.

  26. Changes in medications or doses of medication as follows:

  27. All allowed concomitant medications, supplements, or other substances must be atstable doses for at least 30 days prior to screening and must be kept as stable asmedically possible during the trial. For allowed concomitant medications, any dosingchange within 30 days of Screening may be allowed if, in the opinion of theInvestigator, it will not affect or influence study results.

Study Design

Total Participants: 160
Treatment Group(s): 1
Primary Treatment: NRCT-101SR
Phase: 2/3
Study Start date:
January 25, 2024
Estimated Completion Date:
February 01, 2026

Study Description

a multi-center, randomized, double-blind, placebo-controlled, parallel-arm design, laboratory classroom (LC) clinical trial to evaluate the safety and efficacy of NRCT-101SR (up to to 2,000 mg/day based on LBM) over a 6-week period in approximately 160 pediatric subjects (13-17 years of age) with ADHD. An open label extension (OLE) of 6 weeks will be optional.

Selected sites will collect blood samples for PK from a subset of subjects.

The primary endpoint of the study is Permanent Product Measure of Performance (PERMP) Math Tests and the key secondary endpoint is ADHD Rating Scale (ADHD-RS). The primary analysis will be on effects of 6-week treatment of NRCT-101SR versus placebo on performance (PERMP) in subjects with ADHD.

Connect with a study center

  • Advanced Research Center, Inc

    Anaheim, California 92805
    United States

    Active - Recruiting

  • Accel Research Sites - Lakeland Clinical Research Unit

    Lakeland, Florida 33803
    United States

    Active - Recruiting

  • Accel Research Sites

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • Accel Research Sites Network - Maitland

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • Bio-Medical Research LLC

    Miami, Florida 33144
    United States

    Active - Recruiting

  • CenExel ACMR Atlanta Center for Medical Research

    Atlanta, Georgia 30331
    United States

    Active - Recruiting

  • iResearch Atlanta

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • iRresearch Atlanta

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • CenExel iRS - iResearch Savannah

    Savannah, Georgia 31405
    United States

    Active - Recruiting

  • DelRicht Research

    New Orleans, Louisiana 70155
    United States

    Site Not Available

  • DelRicht Research

    Prairieville, Louisiana 70769
    United States

    Active - Recruiting

  • Boston Clinical Trials Llc

    Boston, Massachusetts 02131
    United States

    Active - Recruiting

  • Center for Psychiatry and Behavioral Medicine

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • Vector Clinical Trials

    Las Vegas, Nevada 89128
    United States

    Active - Recruiting

  • Coastal Carolina Research Center - North Charleston

    North Charleston, South Carolina 29405
    United States

    Active - Recruiting

  • Epic Medical Research - DeSoto

    DeSoto, Texas 75115
    United States

    Active - Recruiting

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