RECRUITING

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

Conditions

Attention-Deficit/Hyperactivity Disorder (ADHD)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-01-25

Study Completion:2025-02-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06215144

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.

Ages Eligible for Study:13 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

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

Inclusion Criteria

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

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.

Contacts and Locations

Study Contact

Mary Miller, MAOM

CONTACT

925-954-4868

mmiller@neurocentria.com

Guy Bar-Klein, PhD

CONTACT

925-954-4868

gbar-klein@neurocentria.com

Principal Investigator

Guy Bar-Klein, PhD

STUDY_DIRECTOR

Nuerocentria

Study Locations (Sites)

Accel Research Sites - Lakeland Clinical Research Unit

Lakeland, Florida, 33803

United States

Accel Research Sites

Maitland, Florida, 32751

United States

CenExel ACMR Atlanta Center for Medical Research

Atlanta, Georgia, 30331

United States

iRresearch Atlanta

Decatur, Georgia, 30030

United States

CenExel iRS - iResearch Savannah

Savannah, Georgia, 31405

United States

Boston Clinical Trials Llc

Boston, Massachusetts, 02131

United States

Center for Psychiatry and Behavioral Medicine

Las Vegas, Nevada, 89128

United States

Coastal Carolina Research Center - North Charleston

North Charleston, South Carolina, 29405

United States

Collaborators and Investigators

Sponsor: Neurocentria, Inc.

Guy Bar-Klein, PhD, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2024-01-25

Study Completion Date2025-02-01

Study Record Updates

Study Start Date2024-01-25

Study Completion Date2025-02-01

Terms related to this study

Additional Relevant MeSH Terms

Attention-Deficit/Hyperactivity Disorder (ADHD)