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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
223
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.
Matching placebo
Collaborative Neuroscience Network
Garden Grove, California, United States
Accel Research Sites
Lakeland, Florida, United States
Accel Research Sites
Maitland, Florida, United States
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.
Time frame: 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.
Time frame: Baseline and Week 6
Change From Baseline Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)
The BRIEF-A is a standardized self-report measure of executive functions/self-regulation in an everyday environment. It includes 75 items with nine overlapping clinical scales including inhibit, self-monitor, plan/organize, shift, initiate, task monitor, emotional control, working memory, and organization of materials. All items are rated in terms of frequency on a 3-point scale (0 = never, 1 = sometimes, 2 = often). Raw scores for each scale are summed for an overall summary score - the Global Executive Composite (GEC) - and T scores (mean = 50, standard deviation = 10) are determined. Lower scores indicate better executive function. Raw scores are presented here on a scale from 0-150.
Time frame: Baseline and Week 6
Change From Baseline in Hospital Anxiety and Depression Scale (HADS)
The HADS consists of 14 items, divided into two 7 item subscales: anxiety (HADS-A) and depression (HADS-D). HADS-A questions reflect a state of generalized anxiety and HADS-D focuses on the concept of anhedonia. Subjects will rate each of the questions on a 4-point scale ranging from 0 (absence) to 3 (extreme presence). Scores will be derived by summing responses for each of the two subscales or for the scale as a whole, and the total score is out of 42, with higher scores indicating higher symptom severity. The HADS-A subscale, scored on a scale from 0-21, will be used in the statistical analysis and presented here.
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Miami Dade Medical Research Institute
Miami, Florida, United States
Velocity Clinical Research - Meridian
Meridian, Idaho, United States
Alcanza Clinical Research Company
Boston, Massachusetts, United States
Center for Psychiatry and Behavioral Medicine
Las Vegas, Nevada, United States
Hassman Research Institute
Berlin, New Jersey, United States
Coastal Carolina Research Center - North Charleston
North Charleston, South Carolina, United States
Time frame: Baseline and Week 6
Change From Baseline in Adult ADHD Quality of Life Scale (AAQoL)
The AAQoL is a 29-item self-reported scale evaluating aspects of quality of life in ADHD patients. It consists of a total score of 4 subscales, including life productivity, psychological health, life outlook, and relationship. Items are scored on a 5-point scale ranging from 1 (not at all/never) to 5 (extremely/very often). Raw scores are transformed to a 0 to 100 scale with higher scores indicating a better quality of life.
Time frame: Baseline and Week 6
Change From Baseline in the Clinical Global Impression - Severity (CGI-S)
The CGI-S is a brief assessment tool that measures clinician's impression of illness severity. Evaluation includes information from the subject and may include information from the subject's medical history, physical exam, or other ratings done at screening. CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill). Lower scores indicate less severe symptoms.
Time frame: Baseline and Week 6
Responder Rate
Responder rate is defined as the proportion of subjects with ≥ 20-point improvement on PERMP-C or ≥ 2-point improvement on CGI-S from Baseline to Week 6.
Time frame: Baseline and Week 6
Change From Baseline in the ADHD Investigator Symptom Rating Scale - Expanded Version (AISRS-EV)
The expanded version of AISRS includes the 18 items of AISRS plus 13 additional items evaluating executive function deficits and emotional dyscontrol. AISRS-EV items are scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with a total score ranging from 0 to 93. Lower scores indicate less severe symptoms
Time frame: Baseline and Week 6