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

Attention-Deficit/Hyperactivity Disorder (ADHD) Clinical Trial

— ADHD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06215144
• Other study ID #: NC-021B
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: January 25, 2024
• Est. completion date: February 1, 2025

Study information

• Verified date: March 2024
• Source: Neurocentria, Inc.
• Contact: Mary Miller, MAOM
• Phone: 925-954-4868
• Email: mmiller[@]neurocentria.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: February 1, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-Deficit/Hyperactivity Disorder (ADHD)
• Hyperkinesis

Intervention

Drug:
• NRCT-101SR
NRCT-101SR is a sustained release formulation.

Locations

Country	Name	City	State
United States	CenExel ACMR Atlanta Center for Medical Research	Atlanta	Georgia
United States	Boston Clinical Trials Llc	Boston	Massachusetts
United States	iRresearch Atlanta	Decatur	Georgia
United States	Accel Research Sites - Lakeland Clinical Research Unit	Lakeland	Florida
United States	Center for Psychiatry and Behavioral Medicine	Las Vegas	Nevada
United States	Accel Research Sites	Maitland	Florida
United States	Coastal Carolina Research Center - North Charleston	North Charleston	South Carolina
United States	CenExel iRS - iResearch Savannah	Savannah	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Neurocentria, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective performance/Permanent Product Measure of Performance (PERMP-C) Math Tests	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	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 6 weeks