Study to Evaluate NRCT-101SR in Adult Attention Deficit Hyperactivity Disorder (ADHD)

Last updated: April 10, 2025
Sponsor: Neurocentria, Inc.
Overall Status: Completed

Phase

2/3

Condition

Attention Deficit/hyperactivity Disorder (Adhd - Adults)

Williams Syndrome

Treatment

NRCT-101-SR

Placebo

Clinical Study ID

NCT05683249
NC-018
  • Ages > 18
  • All Genders

Study Summary

The goal of this clinical trial is to evaluate the efficacy and safety of NRCT-101SR compared to placebo in adult patients with ADHD aged 18 years and older.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female, ≥ 18 years of age at screening

  2. Has a primary diagnosis of ADHD according to the Diagnostic and Statistical Manual,Fifth Edition (DSM-5) classification, confirmed with Mini InternationalNeuropsychiatric Interview (MINI) using DSM-5 probes

  3. AISRS ≥ 26 at screening and baseline, and does not change by more than 25% fromscreening to baseline, except subjects who stop taking ADHD medication afterscreening may have an increase of more than 25%

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

  5. Must be fluent in English, and capable of reading, writing, and communicatingeffectively with others and willing to participate in laboratory classroom

  6. Completion of at least 10 years of formal education

  7. Hearing and Vision ability sufficient to complete cognitive testing, ininvestigator's opinion

  8. Willing and able to give informed consent

  9. Total Body weight (bw) must be ≥ 50 kg and ≤ 105 kg and lean body mass (LBM) must be ≤ 75 kg at screening

  10. Naïve to stimulant or non-stimulant medications used for the treatment of ADHD orhave discontinued stimulants at least 2 weeks and non-stimulants at least 3 weeksprior to randomization

Exclusion

Exclusion Criteria:

  1. Subject is functioning below an age-appropriate level intellectually, as judged bythe investigator.

  2. Lifetime history of severe psychiatric symptoms of major depression requiringhospitalization, bipolar disorder, schizophrenia of schizoaffective disorder,hallucinations, or delusions. Severe comorbid disorders such as PTSD, severeobsessive-compulsive disorder, or other symptomatic presentation that, in theopinion of the examining physician, will contraindicate NRCT-101SR treatment orconfound efficacy or safety assessments. Subjects with mild to moderate forms ofsocial phobia or dysthymia, for instance, may be included.

  3. 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), ora current diagnosis of Tourette's Disorder.

  4. Recent history (within the past 1 year) of suspected substance abuse or dependencedisorder (excluding stable nicotine use) in accordance with DSM-5 criteria. (Note:subject's average nicotine use should not be exceeded during each LC visit)

  5. Current abnormal thyroid function as defined as abnormal screening thyroidstimulating hormone. Treatment for at least 3 months with a stable dose of thyroidmedication is permitted.

  6. Poor kidney function; corrected estimated glomerular filtration rate (eGFRcorr) < 40mL/min/m2

  7. History of significant gastrointestinal disorders, such as chronic diarrhea,irritable bowel syndrome, ulcerative colitis, Crohn's disease, etc.

  8. Female subjects who are pregnant and/or lactating

  9. A "yes" answer to "suicidal ideation" item 4 (active suicidal ideation with someintent to act, without specific plan) or item 5 (active suicidal ideation withspecific plan and intent) on the Columbia-Suicide Severity Rating Scale (C-SSRS)assessment at screening (in the past 12 months).

  10. Has history of severe drug allergy or hypersensitivity to the study medication orits excipients.

  11. Hypermagnesemia; magnesium > 2.5 mg/dL

  12. Reproduction: a. Females of childbearing potential (FOCP) must be either sexually inactiveabstinent) or, if sexually active, must agree to use one of the following acceptablebirth control methods beginning 30 days prior to the first dose of study drug andthroughout the study: i. Simultaneous use of male condom and intra-uterinecontraceptive device placed at least 4 weeks prior to first study drugadministration ii. Surgically sterile male partner iii. Simultaneous use of malecondom and diaphragm with spermicide iv. Established hormonal contraceptive b. Malesmust: i. Use 2 methods of contraception in combination if his female partner is ofchildbearing potential; this combination of contraceptive methods must be used fromthe Baseline Visit to ≥ 1 month after the last dose of study drug, or ii. Have beensurgically sterilized prior to the Screening Visit.

  13. Is currently participating in another clinical trial or has participated in aclinical trial within 30 days prior to the Screening Visit.

  14. Currently living in an institutional facility such as a nursing home

  15. Severe physical disability not associated with cognitive function that limitsability to complete testing (e.g., severe tremor, debilitating arthritis, etc.)

  16. Known history of symptomatic cardiac disease, advanced atherosclerosis, structuralcardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronaryheart disease, transient ischemic attack or stroke or other serious cardiacproblems.

  17. Known family history of sudden cardiac death or ventricular arrhythmia.

  18. Serious or unstable clinically important systemic illness or disease that, in thejudgment of the investigator, is likely to affect cognitive assessment, deteriorate,or affect the subject's safety or ability to complete the study, including hepatic (e.g., Child-Pugh grade C), renal, gastroenterologic, respiratory, cardiovascular,endocrinologic, immunologic, infectious, or hematologic disorders

  19. Has previously participated in a NRCT-101SR investigational study or a study thatincludes the active ingredient of NRCT-101SR

  20. Investigators and their immediate family members are not permitted to participate inthe study.

  21. Consumes more than a weekly average of: 2 drinks / day or more than 3 drinks in anyday for males; 1 drink / day or more than 2 drinks in any day for females

  22. Changes in medications or doses of medication as follows:

  23. All allowed concomitant medications, supplements, or other substances must beat stable doses for at least 30 days prior to screening and must be kept asstable as medically possible during the trial. For allowed concomitantmedications, any dosing change within 30 days of Screening may be allowed if,in the opinion of the investigator, it will not affect or influence studyresults.

Study Design

Total Participants: 223
Treatment Group(s): 2
Primary Treatment: NRCT-101-SR
Phase: 2/3
Study Start date:
February 25, 2023
Estimated Completion Date:
January 17, 2024

Study Description

This is a multi-center, randomized, double-blind, placebo-controlled, parallel-arm design, laboratory classroom (LC) trial to assess the efficacy and safety of NRCT-101SR compared to inactive placebo for the treatment of ADHD in adults aged 18 years and older.

After Screening, Orientation, and Baseline evaluations are complete, eligible subjects will be randomized into one of two groups (1:1) to receive NRCT-101SR or matching placebo orally twice daily, in the morning and evening, beginning the day after the Baseline visit for 6 weeks. Subjects will receive a fixed dose of 1,500 or 2,000 mg/day, based on lean body mass, split evenly between the morning and evening dosing.

Total subject participation in the study is up to approximately 13 weeks, including a screening period (up to 6 weeks), a 6-week treatment period, and an approximate 1-week follow-up period. Within 8 days prior to Baseline LC visit, subjects will complete an LC Orientation Visit. LC visits will be repeated at Week 3 and Week 6.

The primary outcome measures of the study include Permanent Product Measure of Performance (PERMP) Math Tests (number of correctly answered problems; PERMP-C) and ADHD Investigator Symptom Rating Scale (AISRS). At Baseline, Week 3 visit, and Week 6 visit, serial PERMP Math Tests at pre-dose and at 2, 4, 6, 8, 10, and 12 hours post-dose, and AISRS will be administered. LC visits will be repeated at Week 3 and Week 6. Secondary and exploratory assessments will also be conducted at the Baseline, Week 3, and Week 6 LC visits. A clinic visit will be conducted at Week 1. Pharmacokinetic (PK) sampling will be collected at the Week 3 LC visit. Safety assessments (concomitant medications, adverse events, and suicide risk) will be conducted at all clinic and remote visits/phone calls (Week 5, and follow-up); safety labs will be conducted at screening, Week 3, and Week 6.

Connect with a study center

  • Collaborative Neuroscience Network

    Garden Grove, California 92845
    United States

    Site Not Available

  • Accel Research Sites

    Lakeland, Florida 33803
    United States

    Site Not Available

  • Accel Research Sites

    Maitland, Florida 32751
    United States

    Site Not Available

  • Miami Dade Medical Research Institute

    Miami, Florida 33176
    United States

    Site Not Available

  • Velocity Clinical Research - Meridian

    Meridian, Idaho 82642
    United States

    Site Not Available

  • Alcanza Clinical Research Company

    Boston, Massachusetts 02131
    United States

    Site Not Available

  • Center for Psychiatry and Behavioral Medicine

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • Hassman Research Institute

    Berlin, New Jersey 08009
    United States

    Site Not Available

  • Coastal Carolina Research Center - North Charleston

    North Charleston, South Carolina 29405
    United States

    Site Not Available

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