ADHDPhase 2/3NCT05683249
Study to Evaluate NRCT-101SR in Adult Attention Deficit Hyperactivity Disorder (ADHD)
A Phase 2/3 study testing NRCT-101-SR in people with ADHD, run by Neurocentria, Inc. at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ADHD
- What is being tested?
- NRCT-101-SR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 223 participants
- Where
- 9 sitesUnited States
- Study dates
- 25 Feb 2023to 17 Jan 2024
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
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 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
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- 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:
- 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
- Severe physical disability not associated with cognitive function that limits ability to complete testing (e.g., severe tremor, debilitating arthritis, etc.)
- 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 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
- Has previously participated in a NRCT-101SR investigational study or a study that includes the active ingredient of NRCT-101SR
- Investigators and their immediate family members are not permitted to participate in the study.
- Consumes more than a weekly average of: 2 drinks / day or more than 3 drinks in any day for males; 1 drink / day or more than 2 drinks in any day for females
- 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
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Hassman Research Institute
Berlin, New Jersey, 08009
Alcanza Clinical Research Company
Boston, Massachusetts, 02131
Collaborative Neuroscience Network
Garden Grove, California, 92845
Accel Research Sites
Lakeland, Florida, 33803
Center for Psychiatry and Behavioral Medicine
Las Vegas, Nevada, 89128
Accel Research Sites
Maitland, Florida, 32751
Velocity Clinical Research - Meridian
Meridian, Idaho, 82642
Miami Dade Medical Research Institute
Miami, Florida, 33176
Coastal Carolina Research Center - North Charleston
North Charleston, South Carolina, 29405
About this study
Official title: Clinical Trial to Evaluate the Safety and Efficacy of NRCT-101SR in Adult Attention Deficit Hyperactivity Disorder
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.
Read the detailed 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.
- Conditions
- ADHD
- Being tested
- NRCT-101-SR, Placebo
- 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-101-SRDrug
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.
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and Week 6
Secondary outcomes (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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start25 Feb 2023
- Primary completion17 Jan 2024
- Study completion17 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Placebo-controlled, parallel-arm design.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurocentria, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guosong Liu, M.D., Ph.D., Study director, Neurocentria, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683249
- Sponsor's protocol ID
- NC-018
- Status last verified
- May 2025
- First submitted
- 4 Jan 2023
- Last updated
- 3 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate the Safety and Efficacy of NRCT-101SR in Adult Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT05683249
- Acronym / sponsor ID
- NC-018
- Conditions
- ADHD
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Neurocentria, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Feb 2023 (actual)
- Primary completion
- 17 Jan 2024 (actual)
- Study completion
- 17 Jan 2024 (actual)
- First posted
- 13 Jan 2023 (actual)
- Results
- Posted 27 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Placebo-controlled, parallel-arm design.
| Arm | Type | Receives |
|---|---|---|
| NRCT-101SR | Experimental | Drug: NRCT-101-SRTwo-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 |
| Matching Placebo | Placebo comparator | Drug: PlaceboTwo-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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NRCT-101-SRNRCT-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. | Drug | NRCT-101SR |
| PlaceboMatching placebo | Drug | Matching Placebo |
Primary outcome
Change From Baseline in Permanent Product Measure of Performance (PERMP) - Number of Math Problems Answered Correctly (PERMP-C)
Time frame: Baseline and Week 6
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.
Change From Baseline in ADHD Investigator Symptom Rating Scale (AISRS)
Time frame: Baseline and Week 6
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.
6 secondary outcomes
Change From Baseline Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)
Time frame: Baseline and Week 6
Change From Baseline in Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline and Week 6
Change From Baseline in Adult ADHD Quality of Life Scale (AAQoL)
Time frame: Baseline and Week 6
Change From Baseline in the Clinical Global Impression - Severity (CGI-S)
Time frame: Baseline and Week 6
Responder Rate
Time frame: Baseline and Week 6
Change From Baseline in the ADHD Investigator Symptom Rating Scale - Expanded Version (AISRS-EV)
Time frame: Baseline and Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guosong Liu, M.D., Ph.D. study director
Neurocentria, Inc.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing NRCT-101-SR in people with ADHD, run by Neurocentria, Inc. at 9 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 10 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: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
Yes. Results are posted in the registry (first posted 27 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Permanent Product Measure of Performance (PERMP) - Number of Math Problems Answered Correctly (PERMP-C) (time frame: Baseline and Week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2025.