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

NCT05683249 | Completed Phase 2 Results FDA Drug

• 1 other identifier: NC-018
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

ADHD

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Permanent Product Measure of Performance (PERMP) - Number of Math Problems Answered Correctly (PERMP-C)

  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.

  Baseline and Week 6

• Change From Baseline in ADHD Investigator Symptom Rating Scale (AISRS)

  AISRS 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. Lower scores indicate less severe symptoms.

  Baseline and Week 6

Secondary Outcomes (6)

• Change From Baseline Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)

  Baseline and Week 6

• Change From Baseline in Hospital Anxiety and Depression Scale (HADS)

  Baseline and Week 6

• Change From Baseline in Adult ADHD Quality of Life Scale (AAQoL)

  Baseline and Week 6

• Change From Baseline in the Clinical Global Impression - Severity (CGI-S)

  Baseline and Week 6

• Responder Rate

  Baseline and Week 6

Study Arms (2)

NRCT-101SR

EXPERIMENTAL

Two-tiered fixed dose of 1,500 or 2,000 mg/day. Two NRCT-101SR tablets (375 mg or 500 mg based on lean body mass) by mouth twice daily

Drug: NRCT-101-SR

Matching Placebo

PLACEBO COMPARATOR

Two-tiered fixed dose of 1,500 or 2,000 mg/day. Two NRCT-101SR placebo tablets (375 mg or 500 mg based on lean body mass) by mouth twice daily

Drug: Placebo

Interventions

NRCT-101-SR DRUG

NRCT-101SR is a sustained release formulation. Subjects ≥ 50 kg LBM receive a total of four 500 mg tablets/day and subjects \< 50kg LBM receive a total of four 375 mg tablets per day.

NRCT-101SR

Placebo DRUG

Matching placebo

Matching Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, ≥ 18 years of age at screening
• Has a primary diagnosis of ADHD according to the Diagnostic and Statistical Manual, Fifth Edition (DSM-5) classification, confirmed with Mini International Neuropsychiatric Interview (MINI) using DSM-5 probes
• AISRS ≥ 26 at screening and baseline, and does 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 4 on the CGI-S at baseline
• Must be fluent in English, and capable of reading, writing, and communicating effectively with others and willing to participate in laboratory classroom
• Completion of at least 10 years of formal education
• Hearing and Vision ability sufficient to complete cognitive testing, in investigator's opinion
• Willing and able to give informed consent
• Total Body weight (bw) must be ≥ 50 kg and ≤ 105 kg and lean body mass (LBM) must be ≤ 75 kg at screening
• Naïve to stimulant or non-stimulant medications used for the treatment of ADHD or have discontinued stimulants at least 2 weeks and non-stimulants at least 3 weeks prior to randomization

You may not qualify if:

• 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 of 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 (excluding stable nicotine use) in accordance with DSM-5 criteria. (Note: subject's average nicotine use should not be exceeded during each LC visit)
• 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.
• Poor kidney function; corrected estimated glomerular filtration rate (eGFRcorr) \< 40 mL/min/m2
• 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
• 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 Columbia-Suicide Severity Rating Scale (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; magnesium \> 2.5 mg/dL
• Reproduction:
• a. Females of childbearing potential (FOCP) must be either sexually inactive abstinent) or, if sexually active, must agree to use one of the following acceptable birth control methods beginning 30 days prior to the first dose of study drug and throughout the study: i. Simultaneous use of male condom and intra-uterine contraceptive device placed at least 4 weeks prior to first study drug administration ii. Surgically sterile male partner iii. Simultaneous use of male condom and diaphragm with spermicide iv. Established hormonal contraceptive b. Males must: i. Use 2 methods of contraception in combination if his female partner is of childbearing potential; this combination of contraceptive methods must be used from the Baseline Visit to ≥ 1 month after the last dose of study drug, or ii. Have been surgically sterilized prior to the Screening Visit.
• Is currently participating in another clinical trial or has participated in a clinical trial within 30 days prior to the Screening Visit.
• Currently living in an institutional facility such as a nursing home

Sponsors & Collaborators

• Neurocentria, Inc.: lead

Study Sites (9)

Collaborative Neuroscience Network

Garden Grove, California, 92845, United States

Location

Accel Research Sites

Lakeland, Florida, 33803, United States

Location

Accel Research Sites

Maitland, Florida, 32751, United States

Location

Miami Dade Medical Research Institute

Miami, Florida, 33176, United States

Location

Velocity Clinical Research - Meridian

Meridian, Idaho, 82642, United States

Location

Alcanza Clinical Research Company

Boston, Massachusetts, 02131, United States

Location

Center for Psychiatry and Behavioral Medicine

Las Vegas, Nevada, 89128, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Coastal Carolina Research Center - North Charleston

North Charleston, South Carolina, 29405, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Clinical Development
• Organization: Neurocentria Inc.

info@neurocentria.com

925-954-4868

Study Officials

• Guosong Liu, M.D., Ph.D.

  Neurocentria, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Placebo-controlled, parallel-arm design.

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 13, 2023
• Study Start: February 25, 2023
• Primary Completion: January 17, 2024
• Study Completion: January 17, 2024
• Last Updated: June 3, 2025
• Results First Posted: April 27, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)