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Attention-Deficit/Hyperactivity Disorder (ADHD)Phase 2/3ADHDNCT06215144

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

A Phase 2/3 study testing NRCT-101SR in people with Attention-Deficit/Hyperactivity Disorder (ADHD), run by Neurocentria, Inc. at 13 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 13 to 17 years
What is being tested?
NRCT-101SR
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
95 participants
Where
13 sitesUnited States
Study dates
25 Jan 2024to 6 Nov 2025
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Male or female, 13-17 years of age at screening.
  • Has a primary diagnosis of ADHD according to the DSM-5 classification, confirmed with MINI using DSM-5 probes.
  • ADHD-related symptoms - ADHD-RS-5 ≥ 28 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%.
  • Has a minimum score of 5 on the CGI-S at baseline.

Who cannot join

  • Subject is functioning below an age-appropriate level intellectually, as judged by the Investigator.
  • 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.
  • 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.
  • Recent history (within the past 1 year) of suspected substance abuse or dependence disorder in accordance with DSM-5 criteria.
  • 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.
  • History of poor kidney function; corrected estimated glomerular filtration rate (eGFR) < 90 mL/min/m2
Show all 24Show fewer
  • History of significant gastrointestinal disorders, such as chronic diarrhea, irritable bowel syndrome, ulcerative colitis, Crohn's disease, etc.
  • 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.
  • *A woman is considered fertile following menarche unless permanently sterile; a premenarchal female is not considered a WOBCP).
  • 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).
  • Has history of severe drug allergy or hypersensitivity to the study medication or its excipients.
  • Hypermagnesemia; serum magnesium > 2.5 mg/dL.
  • Hepatic impairment as defined by serum AST, ALT and/or ALP > 1.25 ULN, and/or serum bilirubin > 1.5 ULN.
  • Known history of hepatitis B and/or C.:
  • 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 to the Screening Visit.
  • Currently living in an institutional facility.
  • Severe physical disability not associated with cognitive function that limits ability to complete testing.
  • 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.
  • Known family history of sudden cardiac death or ventricular arrhythmia.
  • 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.
  • Has previously participated in a NRCT-101SR / L-TAMS investigational study.
  • Investigators and their immediate family members are not permitted to participate in the study.
  • Changes in medications or doses of medication as follows:
  • 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.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Advanced Research Center, Inc

    Anaheim, California, 92805

  • CenExel ACMR Atlanta Center for Medical Research

    Atlanta, Georgia, 30331

  • Boston Clinical Trials Llc

    Boston, Massachusetts, 02131

  • iResearch Atlanta

    Decatur, Georgia, 30030

  • Epic Medical Research - DeSoto

    DeSoto, Texas, 75115

  • Accel Research Sites - Lakeland Clinical Research Unit

    Lakeland, Florida, 33803

  • Vector Clinical Trials

    Las Vegas, Nevada, 89128

  • Accel Research Sites Network - Maitland

    Maitland, Florida, 32751

  • Bio-Medical Research LLC

    Miami, Florida, 33144

  • DelRicht Research

    New Orleans, Louisiana, 70155

  • Coastal Carolina Research Center - North Charleston

    North Charleston, South Carolina, 29405

  • DelRicht Research

    Prairieville, Louisiana, 70769

  • CenExel iRS - iResearch Savannah

    Savannah, Georgia, 31405

Other trials in United States

About this study

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

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

Read the 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 12-week period in approximately 160 pediatric subjects (13-17 years of age) with ADHD.

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

The primary endpoint of the study is ADHD Rating Scale (ADHD-RS). The primary analysis will be on effects of 12-week treatment of NRCT-101SR versus placebo on ADHD-RS in subjects with ADHD.

Being tested
NRCT-101SR
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NRCT-101SRDrug

    Also called Matching Placebo

    NRCT-101SR is a sustained release formulation.

Study groups in NCT06215144
Study groupRoleWhat they receive
Experimental ArmExperimentalUp to 2,250 mg/day
Receives: Drug: NRCT-101SR
Control ArmPlacebo comparatorMatching placebo
Receives: Drug: NRCT-101SR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: over 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2024
  2. Study start25 Jan 2024
  3. Primary completion10 Oct 2025
  4. Study completion6 Nov 2025

Why it stopped: Slow enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double Blind placebo controlled
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
95 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06215144
Sponsor's protocol ID
NC-021B
Acronym
ADHD
Status last verified
Mar 2025
First submitted
10 Jan 2024
Last updated
15 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing NRCT-101SR in people with Attention-Deficit/Hyperactivity Disorder (ADHD), run by Neurocentria, Inc. at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Core Symptoms/ADHD Rating Scale (ADHD-RS-5) (time frame: over 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06215144.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.

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