Evaluating NRCT-101SR for ADHD in Teens

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

This study is testing a new treatment called NRCT-101SR to see if it can help teenagers aged 13-17 with ADHD improve their focus and performance in school.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 13 Years to 17 Years
• Sex: All
• Sponsor: Neurocentria, Inc. (Industry-sponsored)
• Locations: 13 sites (Anaheim, California and 12 other locations)
• Trial ID: NCT06215144 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of NRCT-101SR in treating Attention-Deficit/Hyperactivity Disorder (ADHD) in pediatric subjects aged 13-17. It employs a multi-center, randomized, double-blind, placebo-controlled design over a 6-week period, involving approximately 160 participants. The primary endpoint focuses on performance measured through the Permanent Product Measure of Performance (PERMP) Math Tests, while the ADHD Rating Scale (ADHD-RS) serves as a key secondary endpoint. An optional open-label extension of 6 weeks will also be available for participants.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 13-17 with a confirmed diagnosis of ADHD and specific symptom severity as measured by ADHD-RS.

Not a fit: Patients with severe psychiatric conditions or those functioning below age-appropriate intellectual levels may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide an effective new option for managing ADHD symptoms in adolescents.

How similar studies have performed: Other studies have shown promise in similar approaches, but the specific treatment NRCT-101SR is being evaluated for its unique efficacy.

Eligibility criteria

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.

Where this trial is running

Anaheim, California and 12 other locations

• Advanced Research Center, Inc — Anaheim, California, United States (Recruiting)
• Accel Research Sites - Lakeland Clinical Research Unit — Lakeland, Florida, United States (Recruiting)
• Accel Research Sites Network - Maitland — Maitland, Florida, United States (Recruiting)
• Bio-Medical Research LLC — Miami, Florida, United States (Recruiting)
• CenExel ACMR Atlanta Center for Medical Research — Atlanta, Georgia, United States (Recruiting)
• iResearch Atlanta — Decatur, Georgia, United States (Recruiting)
• CenExel iRS - iResearch Savannah — Savannah, Georgia, United States (Recruiting)
• DelRicht Research — New Orleans, Louisiana, United States (Not_yet_recruiting)
• DelRicht Research — Prairieville, Louisiana, United States (Recruiting)
• Boston Clinical Trials Llc — Boston, Massachusetts, United States (Recruiting)
• Vector Clinical Trials — Las Vegas, Nevada, United States (Recruiting)
• Coastal Carolina Research Center - North Charleston — North Charleston, South Carolina, United States (Recruiting)
• Epic Medical Research - DeSoto — DeSoto, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Mia Taylor, BS

Conditions Attention-Deficit/Hyperactivity Disorder