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ADHDPhase 3NCT05924594

Phase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301

A Phase 3 study testing CTx-1301 - Dexmethylphenidate 6.25mg, CTx-1301 - Dexmethylphenidate 12.5mg and CTx-1301 - Dexmethylphenidate 18.75mg in people with ADHD and ADHD - Combined Type, run by Cingulate Therapeutics at 3 sites in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

The goal of this clinical trial is to evaluate the efficacy and safety of CTx-1301 in children (6-12) with ADHD in a laboratory classroom setting. Read more about this study

Who is it for?
Ages 6 to 12 years
What is being tested?
CTx-1301 - Dexmethylphenidate 6.25mg, CTx-1301 - Dexmethylphenidate 12.5mg and CTx-1301 - Dexmethylphenidate 18.75mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
3 sitesUnited States
Study dates
31 Jul 2023to Feb 2027
Phase
Phase 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 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Male or female subjects between 6 and 12 years of age (inclusive) at the time of consent.
  • Subject must have a body weight between the 5th and 95th percentile (≥5th percentile and ≤95th percentile) for their respective age and sex.
  • Subject is unsatisfied with his/her current pharmacological therapy for treatment of ADHD or not currently receiving pharmacological therapy for ADHD. Inclusion of subjects who are naïve to pharmacological therapy for ADHD or are newly diagnosed with ADHD is permitted.
  • Females of childbearing potential must have a negative serum b-human chorionic gonadotropin pregnancy test at Screening. Child-bearing potential is defined as any female who has had their first period or is 12 years or older (or will be 12 during the study). Female of childbearing potential or that become child-bearing potential during the study must agree to use a highly effective, medically acceptable form of birth control for 30 days prior to Screening until at least 30 days after the last dose of study drug. Alternatively, subject may remain abstinent until at least 30 days after the last dose of study drug. Episodic abstinence is not reliable to avoid pregnancy, so is not considered a highly effective contraceptive method. Investigator discretion should use judgement and familiarity with the subject's "preferred and usual lifestyle" to assess if reporting of abstinence may be trusted to achieve required effectiveness. Male subjects with female partners must agree at Screening to remain abstinent or agree to use an effective and medically acceptable form of birth control from Screening to 90 days after the last dose of study drug.
  • Subject must be in general good health defined as absence of any clinically significant abnormalities as determined by the Investigator based on physical and neurological examinations, vital signs, ECGs, medical history, and safety laboratory tests at screening. If any of the exams or tests are not within the laboratory reference range, the Investigator must assess and determine if clinically significant.
  • Subject's intellectual function is at an age-appropriate level, as deemed by the Investigator.
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  • Subjects need to be able to perform at least the basic level of problems on the PERMP pre-test with at least 5.5 questions answered correctly per minute performed at Visit 2.
  • Subject must meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for the primary diagnosis of ADHD or any of the three presentations (combined, inattentive, or hyperactive/impulsive presentation) upon clinical evaluation and confirmed by the MINI International Neuropsychiatric Interview of Children and Adolescents (MINI-KID). The MINI-KID should also be used to evaluate any other psychotic disorders.
  • Subject must score 28 or higher on the ADHD-RS-5 scale at the screening visit (Visit 1) and Baseline visit (Visit 2). For subjects requiring washout of ADHD medications, adequate washout of stimulant ADHD medications will be defined as no medication for the previous 5 days. Adequate washout of non-stimulant ADHD medications will be defined as no medication for the previous 21 days.
  • Subject must have a score of 4 (moderately ill) or higher on the clinician-administrated Clinical Global Impressions-Severity (CGI-S) scale at screening (Visit 1). For subjects requiring washout of ADHD medications, adequate washout of stimulant ADHD medications will be defined as no medication for the previous 5 days. Adequate washout of non-stimulant ADHD medications will be defined as no medication for the previous 21 days.
  • Subject must be able and willing to wash out of stimulant ADHD medications (except study drug as indicated per protocol), including herbal medication, from 5 days prior to the start of the dose optimization phase (Visit 2) and for the duration of the entire study, defined as completion of the safety follow-up visit. Additionally, subject must be able and willing to wash out from non-stimulant ADHD medications 21 days prior to the start of the dose optimization phase (Visit 2) and for the duration of the entire study, defined as completion of the safety follow-up visit.
  • Subject and parents/legal guardians, and/or caregiver (if applicable) must be able to read, write, speak, and understand English and be able to communicate with the Investigator and study coordinator in a satisfactory fashion and complete any study-related materials. Subject and parents/legal guardians, and/or caregivers (if applicable) must plan to be available for the entire duration of the study.
  • One or more of the parents/legal guardians, or caregivers of the subject must voluntarily give written permission for him/her to participate in the study.
  • Subject must provide written assent prior to study participation
  • Subject, subject's parents/legal guardians, and/or caregivers (if applicable) must understand and be willing and able to comply with study procedures as well as the visit schedule. If the subject is cared for by a caregiver for relevant portions of the day, the caregiver may be more suitable for certain assessments, and the caregiver will need to agree to the applicable procedures and visits. The most appropriate assessor should be determined prior to the double-blind, randomized, efficacy portion. The assessor for each individual subject should be the same assessor throughout the double-blind, randomized, efficacy portion of the study.
  • Subject must be able to swallow the CTx-1301 tablet as evidenced by ability to swallow a similar size tablet (placebo) at screening.

Who cannot join

  • If female and of child-bearing potential, the subject must not be pregnant or breastfeeding at any time during the study or for 30 days following the completion of the study. If of child-bearing potential, urine hCG tests will be administered at protocol-specified time points. Any positive pregnancy test during the study will exclude them from further participation in the study.
  • Subject has any psychiatric diagnosis of bipolar I or II disorder, major depressive disorder, conduct disorder, disruptive mood dysregulation disorder (DMDD), intellectual disability, obsessive-compulsive disorder, eating disorder, anxiety disorder (including generalized anxiety disorder), any history of psychosis, autism spectrum disorder, a history of motor or vocal tics or Tourette's Syndrome, confirmed genetic disorder with cognitive and/or behavioral disturbances, or any other diagnosis/significant medical history that at the discretion of the Investigator excludes the subject from entry into the study.
  • Subject has evidence of any chronic disease of the central nervous system (CNS) such as tumors, inflammation, seizure disorder (excluding febrile seizures), vascular disorder, potential CNS-related disorders that might occur in childhood, or history of persistent neurological symptoms related to a serious head injury.
  • Subject has any clinically significant and/or unstable/uncontrolled medical abnormality, chronic medical condition, persistent neurological symptoms, history of cardiovascular abnormality, abnormalities of respiratory, hepatic, gastrointestinal, renal, or any disorder or history of a condition that would impact or interfere with drug absorption, distribution, metabolism, or excretion during the study or may interfere with the subject's ability to participate in the study.
  • Subject has family history of early cardiovascular disease or sudden death.
  • Subject has any history of attempted suicide, clinically significant suicidal ideation based on the Columbia Suicide Severity Rating Scale (C-SSRS) assessment, or answers "yes" to "Suicidal Ideation" item 4 or 5 of any lifetime history on the C-SSRS Children's Lifetime/Recent assessment at screening.
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  • Subject has a known primary sleep disorder (e.g., sleep apnea, narcolepsy, etc.)
  • If the subject's blood pressure is < 90th percentile for their age, sex, and height, the single read is sufficient. If the subject's blood pressure is ≥ 90th percentile, two additional reads will be taken, and the three reads will be averaged. If the average of the three readings is ≥ 95th percentile at screening they will be excluded.
  • Subject is considered treatment refractory by the Investigator or is intolerant to stimulant ADHD medication.
  • Any use of anticonvulsants currently or within the past 2 years.
  • Uncontrolled thyroid disorder indicated by thyroid stimulating hormone (TSH) ≤0.8 x the lower limit of normal (LLN) or ≥ 1.25 x the upper limit of normal (ULN) from the reference laboratory.
  • Subject has first-degree relatives (biological parent or sibling) with a history of schizophrenia, schizoaffective disorder, bipolar I disorder, or bipolar II disorder.
  • Subject has history of substance abuse or shows evidence of substance or has a positive urine drug screen at screening and/or baseline. Subjects with positive drug screens may be allowed to continue in the study if the result of the positive drug screen is from prescribed medications and the subject is willing to washout of the medication as required per protocol.
  • Previous treatment experience/exposure to CTx-1301.
  • Subject has a history of allergic reaction or sensitivity to methylphenidate, dexmethylphenidate, or any other substance contained in CTx-1301 or the placebo drug.
  • Subject has participated in a classroom study within 6 months prior to the start of Screening or has participated in any other clinical study with an investigational drug/product within 30 days prior to Screening or is currently participating in another clinical study.
  • Subject's family anticipates a move outside the geographic range of the investigative site during the duration of the study period or plans on travel that would not allow compliance to the protocol during the study period.
  • Subject is unsuitable in any other way, to participate in the study, as determined by the Investigator.
  • Subject is a family member of an employee at the study center, of the investigator, or those with direct involvement in the proposed study under the direction of that investigator or study center.
  • Subjects that are siblings are not allowed to be in the same cohort.
  • Eligibility Criteria (end of dose-optimization phase)
  • Subjects will be required to meet the following additional eligibility criteria at the end of the dose-optimization phase (Visit 10) to enter into the double-blind, randomized phase. These criteria are based on the efficacy and safety observed over the 8-week dose-optimization period.
  • A minimum of 2 weeks on optimal dose
  • A reduction of greater than or equal to 30% reduction of the ADHD-RS-5 from Visit 2 to Visit 10 (plus or minus 3 days) during the dose-optimization phase.
  • A CGI-I score of 1 or 2 points ("Very much improved" or "Much improved") at the end of the dose optimization phase (Visit 10 (plus or minus 3 days)).
  • Acceptable tolerability of the optimized CTx-1301 dose during the optimization phase (Visit 2 - Visit 10 (plus or minus 3 days)).

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Center for Psychiatry & Behavioral Medicine

    Las Vegas, Nevada, 89128

  • Accel Research Sites

    Maitland, Florida, 32751

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405

Other trials in United States

About this study

Official title: A Phase 3, Dose-Optimized, Double-Blind, Randomized, Placebo-Controlled, Parallel Efficacy and Safety Laboratory Classroom Study in Children (6-12) With Attention-Deficit/Hyperactivity Disorder (ADHD) Using CTx-1301 (Dexmethylphenidate)

The goal of this clinical trial is to evaluate the efficacy and safety of CTx-1301 in children (6-12) with ADHD in a laboratory classroom setting.

Read the detailed description

A Phase 3, dose-optimized, randomized, double-blind, placebo-controlled, dose-optimized, parallel efficacy and safety laboratory classroom study in children (6-12) with ADHD.

The study will be comprised of a screening period, a dose-optimization phase, a double-blind randomized phase, and a safety follow-up phase. Subjects will undergo a screening visit prior to entering into a 8-week dose-optimization phase. During the dose-optimization phase, subjects will have weekly visits and will be titrated to doses ranging between 6.25mg-37.5mg of CTx-1301. Eligible subjects will be randomized phase to their optimal dose or placebo in a 1:1 ratio at the end of Visit 10 completing the practice laboratory classroom study. Subjects will take their assigned/randomized dose over the following 7-day period. On the 7th days subjects will complete the full laboratory classroom study. The duration of the full laboratory classroom study will be approximately 15 hours. Subjects will have an in-clinic safety follow-up visit within 7 days after the full classroom day.

Being tested
CTx-1301 - Dexmethylphenidate 6.25mg, CTx-1301 - Dexmethylphenidate 12.5mg, CTx-1301 - Dexmethylphenidate 18.75mg, CTx-1301 - Dexmethylphenidate 25.0mg, CTx-1301 - Dexmethylphenidate 31.25mg
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.

  • CTx-1301 - Dexmethylphenidate 6.25mgDrug

    Also called 6.25mg CTx-1301 (Dexmethylphenidate tablet)

    All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 6.25mg, 12.5mg, 18.75mg, 25.0mg, 31.25mg, or 37.5mg of CTx-1301.

  • CTx-1301 - Dexmethylphenidate 12.5mgDrug

    Also called 12.5mg CTx-1301 (Dexmethylphenidate tablet)

    All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 6.25mg, 12.5mg, 18.75mg, 25.0mg, 31.25mg, or 37.5mg of CTx-1301.

  • CTx-1301 - Dexmethylphenidate 18.75mgDrug

    Also called 18.75mg CTx-1301 (Dexmethylphenidate tablet)

    All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 6.25mg, 12.5mg, 18.75mg, 25.0mg, 31.25mg, or 37.5mg of CTx-1301.

  • CTx-1301 - Dexmethylphenidate 25.0mgDrug

    Also called 25.0mg CTx-1301 (Dexmethylphenidate tablet)

    All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 6.25mg, 12.5mg, 18.75mg, 25.0mg, 31.25mg, or 37.5mg of CTx-1301.

  • CTx-1301 - Dexmethylphenidate 31.25mgDrug

    Also called 31.25mg CTx-1301 (Dexmethylphenidate tablet)

    All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 6.25mg, 12.5mg, 18.75mg, 25.0mg, 31.25mg, or 37.5mg of CTx-1301.

  • CTx-1301 - Dexmethylphenidate 37.5mgDrug

    Also called 37.5mg CTx-1301 (Dexmethylphenidate tablet)

    All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 6.25mg, 12.5mg, 18.75mg, 25.0mg, 31.25mg, or 37.5mg of CTx-1301.

  • PlaceboDrug

    Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomized phase.

Study groups in NCT05924594
Study groupRoleWhat they receive
Experimental: 6.25mg CTx-1301 (Dexmethylphenidate tablet)ExperimentalAll subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 6.25mg, 12.5mg, 18.75mg, 25.0mg, 31.25mg, or 37.5mg. The starting dose for all subjects at Day 0 is 6.25mg. Each subject is expected to be on their optimal dose for 2 sequential weeks prior to the randomization phase. Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.
Receives: Drug: CTx-1301 - Dexmethylphenidate 6.25mg
Experimental: 12.5mg CTx-1301 (Dexmethylphenidate tablet)ExperimentalAll subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 6.25mg, 12.5mg, 18.75mg, 25.0mg, 31.25mg, or 37.5mg. The starting dose for all subjects at Day 0 is 6.25mg. Each subject is expected to be on their optimal dose for 2 sequential weeks prior to the randomization phase. Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.
Receives: Drug: CTx-1301 - Dexmethylphenidate 6.25mg; Drug: CTx-1301 - Dexmethylphenidate 12.5mg
Experimental: 18.75mg CTx-1301 (Dexmethylphenidate tablet)ExperimentalAll subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 6.25mg, 12.5mg, 18.75mg, 25.0mg, 31.25mg, or 37.5mg. The starting dose for all subjects at Day 0 is 6.25mg. Each subject is expected to be on their optimal dose for 2 sequential weeks prior to the randomization phase. Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.
Receives: Drug: CTx-1301 - Dexmethylphenidate 6.25mg; Drug: CTx-1301 - Dexmethylphenidate 12.5mg; Drug: CTx-1301 - Dexmethylphenidate 18.75mg
Experimental: 25.0mg CTx-1301 (Dexmethylphenidate tablet)ExperimentalAll subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 6.25mg, 12.5mg, 18.75mg, 25.0mg, 31.25mg, or 37.5mg. The starting dose for all subjects at Day 0 is 6.25mg. Each subject is expected to be on their optimal dose for 2 sequential weeks prior to the randomization phase. Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.
Receives: Drug: CTx-1301 - Dexmethylphenidate 6.25mg; Drug: CTx-1301 - Dexmethylphenidate 12.5mg; Drug: CTx-1301 - Dexmethylphenidate 18.75mg; Drug: CTx-1301 - Dexmethylphenidate 25.0mg
Experimental: 31.25mg CTx-1301 (Dexmethylphenidate tablet)ExperimentalAll subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 6.25mg, 12.5mg, 18.75mg, 25.0mg, 31.25mg, or 37.5mg. The starting dose for all subjects at Day 0 is 6.25mg. Each subject is expected to be on their optimal dose for 2 sequential weeks prior to the randomization phase. Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.
Receives: Drug: CTx-1301 - Dexmethylphenidate 6.25mg; Drug: CTx-1301 - Dexmethylphenidate 12.5mg; Drug: CTx-1301 - Dexmethylphenidate 18.75mg; Drug: CTx-1301 - Dexmethylphenidate 25.0mg; Drug: CTx-1301 - Dexmethylphenidate 31.25mg
Experimental: 37.5mg CTx-1301 (Dexmethylphenidate tablet)ExperimentalAll subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 6.25mg, 12.5mg, 18.75mg, 25.0mg, 31.25mg, or 37.5mg. The starting dose for all subjects at Day 0 is 6.25mg. Each subject is expected to be on their optimal dose for 2 sequential weeks prior to the randomization phase. Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.
Receives: Drug: CTx-1301 - Dexmethylphenidate 6.25mg; Drug: CTx-1301 - Dexmethylphenidate 12.5mg; Drug: CTx-1301 - Dexmethylphenidate 18.75mg; Drug: CTx-1301 - Dexmethylphenidate 25.0mg; Drug: CTx-1301 - Dexmethylphenidate 31.25mg; Drug: CTx-1301 - Dexmethylphenidate 37.5mg
Placebo Comparator: PlaceboPlacebo comparatorSubjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomization phase.
Receives: Drug: Placebo

What is being measured

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

  1. Change from baseline (pre-dose measured at Day 63) of the Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale (SKAMP)-combined scores collected across the 14-hour classroom day.

    The Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) is a validated rating of subjective impairment of classroom behaviors. It is a 13-item scale, grouped by subcategories of attention, deportment, quality of work, and compliance. Subjects are rated according to a 7-point scale of impairment, with 0 being none and 6 being maximal impairment. A higher SKAMP score signifies greater impairment.

    Measured: Baseline (pre-dose at Day 63) and at 0.5, 1, 3, 6, 9, 12, 13 and 14 hours post-dose during the full classroom day on Day 63.

Secondary outcomes (5)

  1. Secondary Outcome Measure - Laboratory Classroom Onset and Duration

    Onset and duration of the clinical effect of CTx-1301 during the 14-hour classroom day.

    The Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) is a validated rating of subjective impairment of classroom behaviors. It is a 13-item scale, grouped by subcategories of attention, deportment, quality of work, and compliance. Subjects are rated according to a 7-point scale of impairment, with 0 being none and 6 being maximal impairment. A higher SKAMP score signifies greater impairment.

    Measured: Baseline (pre-dose at Day 63) and at 0.5, 1, 3, 6, 9, 12, 13 and 14 hours post-dose during the full classroom day on Day 63.

  2. Secondary Outcome Measure - CGI-S

    Change from baseline (pre-dose measured at Day 0) of Clinical Global Impression - Severity (CGI-S) scores to CGI-S at Day 63.

    The CGI-S is a clinician-rated scale that evaluates the severity of ADHD symptoms on a scale from 1 (not at all ill) to 7 (among the most severely ill).

    Measured: Baseline (pre-dose measured at Day 0) to Day 63 (approximately 9 weeks).

  3. Secondary Outcome Measure - SKAMP

    Mean of the changes from baseline (pre-dose measured at Day 63) of the Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale (SKAMP)-Deportment scores (SKAMP-D) and (SKAMP)-Attention scores (SKAMP-A) collected across the 14-hour classroom day.

    The Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) is a validated rating of subjective impairment of classroom behaviors. It is a 13-item scale, grouped by subcategories of attention, deportment, quality of work, and compliance. Subjects are rated according to a 7-point scale of impairment, with 0 being none and 6 being maximal impairment. A higher SKAMP score signifies greater impairment.

    Measured: Baseline (pre-dose at Day 63) and at 0.5, 1, 3, 6, 9, 12, 13 and 14 hours post-dose during the full classroom day on Day 63.

  4. Secondary Outcome Measure - PERMP-C

    Change from baseline (pre-dose measured at Day 63) of the Permanent Product Measure of Performance - Correct (PERMP-C) scores collected across the 14-hour classroom day.

    Measured: Baseline (pre-dose at Day 63) and at 0.5, 1, 3, 6, 9, 12, 13 and 14 hours post-dose during the full classroom day on Day 63.

  5. Secondary Outcome Measure - CGI-I

    While CGI-I will be analyzed using the mean change from Baseline (pre-dose at Day 63) compared to Day 63

    Measured: Baseline (pre-dose at Day 63) compared to Day 63

Timeline

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

  1. First posted29 Jun 2023
  2. Study start31 Jul 2023
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Why it stopped: Continuation of the study is not required for NDA submission via the 505(b)(2) pathway

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05924594
Sponsor's protocol ID
CTx-1301-004
Status last verified
Apr 2026
First submitted
21 Jun 2023
Last updated
5 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Overall study data as required by FDAAA801 will be shared upon completion of the study

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CTx-1301 - Dexmethylphenidate 6.25mg, CTx-1301 - Dexmethylphenidate 12.5mg and CTx-1301 - Dexmethylphenidate 18.75mg in people with ADHD and ADHD - Combined Type, run by Cingulate Therapeutics at 3 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 16 inclusion and 26 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: paused, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 phase mean?

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?

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?

Change from baseline (pre-dose measured at Day 63) of the Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale (SKAMP)-combined scores collected across the 14-hour classroom day. (time frame: Baseline (pre-dose at Day 63) and at 0.5, 1, 3, 6, 9, 12, 13 and 14 hours post-dose during the full classroom day on Day 63.). 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 NCT05924594.

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 5 May 2026.

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