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

March 19, 2024 updated by: Neurocentria, Inc.

A Phase 2/3 Randomized Double-Blind Placebo Controlled Clinical Trial to Evaluate the Safety and Efficacy of NRCT-101SR in Pediatric Subjects With Attention-Deficit/Hyperactivity Disorder

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Lakeland, Florida, United States, 33803
        • Not yet recruiting
        • Accel Research Sites - Lakeland Clinical Research Unit
        • Contact:
        • Principal Investigator:
          • Rose Negron
      • Maitland, Florida, United States, 32751
        • Recruiting
        • Accel Research Sites
        • Contact:
        • Principal Investigator:
          • Andrea Marraffino, M.D.
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Recruiting
        • Cenexel ACMR Atlanta Center for Medical Research
        • Principal Investigator:
          • Maria Johnson
        • Contact:
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • iRresearch Atlanta
        • Principal Investigator:
          • Kimball Johnson
        • Contact:
        • Contact:
      • Savannah, Georgia, United States, 31405
        • Recruiting
        • CenExel iRS - iResearch Savannah
        • Contact:
        • Principal Investigator:
          • Yeal Elfassy
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Not yet recruiting
        • Center for Psychiatry and Behavioral Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ann Childress, M.D.
    • South Carolina
      • North Charleston, South Carolina, United States, 29405
        • Not yet recruiting
        • Coastal Carolina Research Center - North Charleston
        • Contact:
        • Principal Investigator:
          • Paul Robbines

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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, confirmed with 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, except subjects who stop taking ADHD medication after screening may have an increase of more than 25%.

  4. Has a minimum score of 4 on the CGI-S at baseline.

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 level in orientation.
  3. Subject is functioning below an age-appropriate level intellectually, as judged by the Investigator.
  4. 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.
  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), or a current diagnosis of Tourette's Disorder.
  6. Recent history (within the past 1 year) of suspected substance abuse or dependence disorder in accordance with DSM-5 criteria.
  7. 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.
  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 of childbearing potential (WOCBP) not agreeing to use birth control methods outlined in inclusion criterion.
  11. *A woman is considered fertile following menarche unless permanently sterile; a premenarchal female is not considered a WOBCP).
  12. 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).
  13. Has history of severe drug allergy or hypersensitivity to the study medication or its 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 serum bilirubin > 1.5 ULN.
  16. Known history of hepatitis B and/or C.:
  17. 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
  18. to the Screening Visit.
  19. Currently living in an institutional facility.
  20. Severe physical disability not associated with cognitive function that limits ability to complete testing.
  21. Known history of symptomatic cardiac disease, advanced atherosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary heart disease, transient ischemic attack or stroke or other serious cardiac problems.
  22. Known family history of sudden cardiac death or ventricular arrhythmia.
  23. Serious or unstable clinically important systemic illness or disease that, in the judgment 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 hematologic disorders.
  24. Has previously participated in a NRCT-101SR / L-TAMS investigational study.
  25. Investigators and their immediate family members are not permitted to participate in the study.
  26. Changes in medications or doses of medication as follows:
  27. All allowed concomitant medications, supplements, or other substances must be at stable doses for at least 30 days prior to screening and must be kept as stable as medically possible during the trial. For allowed concomitant medications, any dosing change within 30 days of Screening may be allowed if, in the opinion of the Investigator, it will not affect or influence study results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Arm
Up to 2,000 mg/day
Drug: NRCT-101SR
NRCT-101SR is a sustained release formulation.
Other Names:
  • Matching Placebo
Placebo Comparator: Control Arm
Matching placebo
Drug: NRCT-101SR
NRCT-101SR is a sustained release formulation.
Other Names:
  • Matching Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective performance/Permanent Product Measure of Performance (PERMP-C) Math Tests
Time Frame: over 6 weeks
PERMP is a skill adjusted math test. PERMP-C is the number of math problems answered correctly in a 10-minute session and typically ranges from 0-400 with higher scores indicating better performance. The mean of the post-dose timepoint scores will be used for evaluation.
over 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Core Symptoms/ADHD Rating Scale (ADHD-RS-5)
Time Frame: Over 6 weeks
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 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurocentria, Inc.

Investigators

  • Study Director: Guy Bar-Klein, PhD, Nuerocentria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2024

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

January 10, 2024

First Submitted That Met QC Criteria

January 19, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NC-021B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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