Attention Deficit/Hyperactivity DisorderPhase 4KP415P01NCT05685732
An Efficacy and Safety Study w/ Azstarys® in Children 4-12 Years of Age With ADHD
A Phase 4 study testing Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH) in people with Attention Deficit/Hyperactivity Disorder, run by Corium, Inc. at 20 sites in United States.
Trial summary
This is a multicenter, dose-optimized, randomized, double-blind, placebo controlled, efficacy and safety study with Azstarys® in children 4 to 12 years of age with attention-deficit/hyperactivity disorder (ADHD). Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Attention Deficit/Hyperactivity Disorder
- What is being tested?
- Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 246 participants
- Where
- 20 sitesUnited States
- Study dates
- 22 Mar 2023to 2 May 2024
- Phase
- Phase 4
- 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- In Cohort 1, subjects must be at least 4 years old and less than 5 years and 10 months at Screening; in Cohort 2, subjects must be at least 6 years old and less than 12 years and 10 months at Screening.
- Subjects must have a body weight within the 5th and 95th percentile according to the gender-specific weight-for-age percentile charts from the Centers for Disease Control and Prevention (CDC). See calculator at https://www.infantchart.com/child/.
- Female subjects must agree, if they are of childbearing potential at Screening or when they become of childbearing potential during the study, to remain abstinent or agree to use an effective and medically acceptable form of birth control from the time of written or verbal assent to at least 14 days after the last dose of study drug. Childbearing potential is defined as follows: Girls under the age of 12 who have not had their first period will be considered "not of child-bearing potential." Girls 12 years of age (including girls who will become 13 years during the study) will be considered "of child-bearing potential," even if they have not yet had their first period. Irrespective of age, girls who have had their first period, will be considered "of child-bearing potential."
- Subjects must be in general good health defined as the absence of any clinically relevant abnormalities as determined by the Investigator based on physical examinations, vital signs, electrocardiograms (ECGs), medical history, and clinical laboratory values (chemistry, hematology, urinalysis) at Screening. If any of the chemistry or hematology tests are not within the laboratory's reference range, then the subject can be included only if the Investigator determines the deviations to be not clinically relevant.
- At least one parent/legal guardian of the subject must voluntarily give written permission for him/her to participate in the study.
- Subjects in Cohort 2 must give written or verbal assent prior to study participation. For verbal assent, the procedure will be documented and signed by a witness. A parent or guardian may not be the witness for a child's verbal assent document.
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- Subject must meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for a primary diagnosis of ADHD (combined, inattentive, or hyperactive/impulsive presentation) per clinical evaluation and confirmed by Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI Kid).
- Subject has had ADHD symptoms present for at least 6 months prior to the Screening Visit.
- Subject must be able and willing to wash out current stimulant ADHD medications, including herbal medications, from 5 days prior to the start of the Treatment Period, and abstain from taking these to the end of Visit 6 or ET; and wash out non-stimulant ADHD medications from 14 days prior to the start of the Treatment Period, and abstain from taking these to the end of Visit 6.
- Subject must have a score of ≥4 (Moderately Ill) on the clinician-administered Clinical Global Impressions-Severity (CGI-S) scale. For subjects requiring washout of ADHD medications, this criterion refers to a score following washout.
- Subjects must have age and sex adjusted ratings of ≥90th percentile Total Score on the ADHD-Rating Scale (ADHD-RS) rated over the past 6 months (for 4- and 5-year old children, use Preschool Version of ADHD-RS-IV; for 6-12 years old children, use ADHD-RS-5).
- Subject functions at an age-appropriate level intellectually, as determined by the Investigator.
- Subject must have a systolic and diastolic blood pressure below the 95th percentile for age and gender according to the 2017 AAP guidelines (Flynn 2017) based on the average of 3 measurements 2-5 minutes apart.
- Subject, subject's parent/legal guardian, and caregiver (if applicable) must understand and be willing and able to comply with all study procedures and visit schedule.
- Subject, parent/legal guardian, and caregiver (if applicable) must be able to speak and understand English or Spanish and be able to communicate satisfactorily with the Investigator and study coordinator.
Who cannot join
- If female, must not be pregnant or breastfeeding, and if of childbearing potential, must have a negative urine pregnancy test at the start of the Screening Period. In addition, a positive pregnancy test before the last dose of study drug will result in early termination from the study.
- Subject with any clinically significant chronic medical condition that, in the judgment of the Investigator, may interfere with the participant's ability to participate in the study.
- Subject has any diagnosis of bipolar I or II disorder, major depressive disorder, conduct disorder, obsessive-compulsive disorder, any history of psychosis, autism spectrum disorder, disruptive mood dysregulation disorder (DMDD), intellectual disability, Tourette's Syndrome, confirmed genetic disorder with cognitive and/or behavioral disturbances. Subjects with oppositional defiant disorder (ODD) are permitted to enroll in the study as long as ODD is not the primary focus of treatment, and, in the opinion of the Investigator, the ODD is mild to moderate, and eligible subjects with ODD are appropriate and cooperative during Screening.
- Subject has generalized anxiety disorder or panic disorder that has been the primary focus of treatment at any time during the 12 months prior to Screening or that has required pharmacotherapy any time during the 6 months prior to Screening.
- Subject has evidence of any chronic disease of the central nervous system (CNS) such as tumors, inflammation, seizure disorder, depression, vascular disorder, potential CNS-related disorders that might occur in childhood (e.g., Duchenne Muscular dystrophy, myasthenia gravis, or other neurologic or serious neuromuscular disorders), or history of persistent neurological symptoms attributable to serious head injury.
- Subject taking anticonvulsants for seizure control or antidepressants currently or within the past 2 years before Screening are not eligible for study participation. A past history of febrile seizure or drug-induced seizure is allowed.
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- Subject has a current (last month) psychiatric diagnosis other than specific phobia, motor skills disorders, ODD, sleep disorders, elimination disorders, adjustment disorders, learning disorders, or communication disorders. Subjects allowed to enroll with any of these DSM disorders will require written justification from the Investigator documenting why the conditions will not interfere with participation and to emphasize that ADHD is the primary indication.
- In the opinion of the Investigator, subject has clinically significant suicidal ideation/behavior, based on history of attempted suicide and the Columbia-Suicide Severity Rating Scale (C-SSRS) assessment at Screening.
- Subject has any clinically significant unstable medical abnormality, chronic disease (including asthma or diabetes), or a history of a clinically significant abnormality of the cardiovascular (including cardiomyopathy, serious arrhythmias, structural cardiac disorders, or severe hypertension), gastrointestinal, respiratory, hepatic, or renal systems, or a disorder or history of a condition (e.g., malabsorption, gastrointestinal surgery) that may interfere with absorption, distribution, metabolism, or excretion of study drug. In cases in which the impact of the condition upon risk to the subject or study results is unclear, the medical monitor should be consulted. Any subject with a known cardiovascular disease or condition (even if controlled) must be discussed with the Medical Monitor during Screening.
- Subject has a history or presence of abnormal ECGs, which in the Investigator's opinion is clinically significant.
- Subject has a history of, or currently has, a malignancy.
- Subject has uncontrolled thyroid disorder as evidenced by thyroid stimulating hormone (TSH) ≤0.8 x the lower limit of normal (LLN) or ≥1.25 x the upper limit of normal (ULN) for the reference laboratory at Screening.
- Subject has greater than trace proteinuria in the urinalysis at Screening. Subjects with greater than trace proteinuria in the urinalysis at Screening but with a urine protein to creatinine (UP/C) ratio <0.2 in a first morning void urine sample will not be excluded from enrollment.
- Subjects has a current or recent (past 12 months) history of drug abuse; or current or recent history of drug abuse in someone living in the subject's home, or are using or planning to use prohibited drugs during the trial as specified in the protocol.
- Subject has a positive urine drug screen at Screening. Subjects with a positive methylphenidate (MPH) urine drug screen may be allowed to continue in the study, provided that the Investigator determines that the positive test is a result of taking prescribed medications and subject is willing to wash out the current medication as required.
- Subject has participated in any other clinical study with an investigational drug/product within 30 days or at least 5 half-lives, whichever is longer, prior to Screening.
- Subject has taken ADHD medications from more than one class within 30 days prior to Screening. Subjects on a stable dose of one ADHD medication with occasional use of ADHD medications from another class are eligible at the discretion of the Investigator.
- Subjects with demonstrated lack of response or intolerability to adequate dose and duration of treatment with MPH products. Judgment of adequate dose and duration is at the discretion of the Investigator.
- Subject has a positive urine MPH screen by dipstick (e.g., NarcoCheck®) at Visit 2.
- Subject is planning to initiate psychotherapy during the study (subjects participating in psychotherapy beginning at least 4 weeks before study initiation are permitted to continue).
- Subject has a history of severe allergies or adverse drug reactions to more than one class of medications.
- Subject has a history of allergic reaction or a known or suspected sensitivity to MPH or any substance that is contained in the study drug.
- Subject, parent/legal guardian, and caregiver (if applicable, at the Investigator's discretion) has commitments during the study that would interfere with attending study visits.
- Subject or subject's family anticipates a move outside the geographic range of the investigative site during the study period, or plans extended travel inconsistent with the recommended visit interval during study duration.
- Subject has one or more siblings living in the same household who are enrolled in this or another clinical drug trial.
- Subject shows evidence of current physical, sexual, or emotional abuse.
- Subject is, in the opinion of the Investigator, unsuitable in any other way to participate in this study.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Advanced Research Center (ARC)
Anaheim, California, 92805
Sky Clinical Research Network Group P.C.
Atlanta, Georgia, 30339
Houston Clinical Trials
Bellaire, Texas, 77401
IMMUNOe International Research Center
Centennial, Colorado, 80112
CenExel IResearch, LLC - Decatur
Decatur, Georgia, 30030
Clinical Neuroscience Solutions - Jacksonville
Jacksonville, Florida, 32256
Accel Research Sites - Lakeland
Lakeland, Florida, 33803
Center for Psychiatry and Behavioral Medicine Inc
Las Vegas, Nevada, 89128
Alivation Research, LLC
Lincoln, Nebraska, 68526
Preferred Research Partners (PRP)
Little Rock, Arkansas, 72211
Accel Research Sites - Maitland
Maitland, Florida, 32751
Clinical Neuroscience Solutions--Memphis
Memphis, Tennessee, 38119
South Florida Research Phase I-IV INC
Miami Springs, Florida, 33166
Boeson Research
Missoula, Montana, 75093
DelRicht Research - Touro Medical Center
New Orleans, Louisiana, 70115
CNS Healthcare - Orlando
Orlando, Florida, 32801
AIM Trials
Plano, Texas, 75093
St Charles Psychiatric Associates & Midwest Research Group
Saint Charles, Missouri, 80112
Flourish Research
San Antonio, Texas, 78229
CenExel iResearch, LLC
Savannah, Georgia, 31405
About this study
Official title: A Multicenter, Dose-Optimized, Randomized, Double Blind, Efficacy and Safety Study With Azstarys® in Children 4 to 12 Years of Age With Attention Deficit/Hyperactivity Disorder
This is a multicenter, dose-optimized, randomized, double-blind, placebo controlled, efficacy and safety study with Azstarys® in children 4 to 12 years of age with attention-deficit/hyperactivity disorder (ADHD). Azstarys® contains dexmethylphenidate (d-MPH) and serdexmethylphenidate (SDX), a prodrug of d-MPH and is orally administered. The primary objective is to determine the efficacy of Azstarys® compared to placebo in treating children ages 4 to 12 years old with ADHD. The study will consist of two randomized and blinded treatment cohorts ages 4 to 5 years of age and 6 to 12 years of age. Randomization will be applied separately with a starting dose up-titration at different dose levels for each cohort. 130 and 100 subjects will be enrolled, respectively. Approximately 20 sites will participate.
Read the detailed description
- Screening Period (Visit 1) Subjects will undergo a screening period up to 30 days prior to entering the Treatment Period.
- Double-Blind Treatment Period (Visit 2 through Visit 6, approx. 28 days) Eligible subjects will be randomized in a blinded fashion to Azstarys® or placebo at the start of the Treatment Period. Randomization will be applied separately in each cohort and stratified by gender.
- Cohort 1: Subjects 4 and 5 years (<6 years) will start at 13.1 mg/2.6 mg or matching placebo and may be titrated up or down to doses of 13.1 mg/2.6 mg, 26.1 mg/5.2 mg, or 39.2 mg/7.8 mg Azstarys® or matching placebo approximately each week through Visit 5 (Day 21)
- Cohort 2: Subjects 6-12 years (<13 years) will start at 39.2 mg/7.8 mg or matching placebo and may be titrated up or down to doses of 26.1 mg/5.2 mg, 39.2 mg/7.8 mg, or 52.3 mg/10.4 mg Azstarys® or matching placebo approximately each week through Visit 5 (Day 21) Subjects who participate in Cohort 1 and successfully complete the Treatment Period will have the option to participate in a 12-month open-label safety study with Azstarys®.
- Conditions
- Attention Deficit/Hyperactivity Disorder
- Being tested
- Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH), 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.
Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)Drug
Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)
placeboOther
matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: SDX/d-MPH in 4-5 year old | Experimental | 13.1 mg/2.6 mg SDX/d-MPH, 26.1 mg/5.2 mg SDX/d-MPH, 39.2 mg/7.8 mg SDX/d-MPH Receives: Drug: Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH) |
| Cohort 1: Placebo in 4-5 year old | Placebo comparator | matching placebo Receives: Other: placebo |
| Cohort 2: SDX/d-MPH in 6-12 year old | Experimental | 26.1 mg/5.2 mg SDX/d-MPH, 39.2 mg/7.8 mg SDX/d-MPH, 52.3 mg/10.4 mg SDX/d-MPH Receives: Drug: Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH) |
| Cohort 2: Placebo in 6-12 year old | Placebo comparator | matching placebo Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
A Comparison of the Change in Mean ADHD Rating Scale (ADHD-RS) Results From Baseline to End of Treatment Between Active and Placebo Treatments.
The ADHD-RS is an 18-item scale based on Diagnostic and Statistical Manual of Mental Disorders criteria of ADHD that rates symptoms on a 4-point scale. Each item is scored using a combination of severity and frequency ratings from a range of 0 (reflecting no symptoms or a frequency of never or rarely) to 3 (reflecting severe symptoms or a frequency of very often), so that the total ADHD-RS scores range from 0 to 54. Scores will be obtained during a clinician-directed interview with the parent/guardian/caregiver at each visit.
Measured: 4 weeks
Secondary outcomes (2)
A Comparison of the Change in Mean Clinical Global Impressions-Severity (CGI-S) Results From Baseline to End of Treatment Between Active and Placebo Treatments.
The CGI-S is a clinician-rated scale that evaluates the severity of ADHD symptoms in the study on a scale from 1 (not at all ill) to 7 (among the most severely ill).
Measured: 4 weeks
A Comparison of the Change in Mean Clinical Global Impressions-Improvement (CGI-I) Results From Visit 3 to End of Treatment Between Active and Placebo Treatments.
The CGI-I is a clinician-rated scale that evaluates the improvement of ADHD symptoms in the study on a scale from 1 (very much improved) to 7 (very much worse).
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start22 Mar 2023
- Primary completion2 May 2024
- Study completion2 May 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 Attention Deficit/Hyperactivity DisorderStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The primary endpoint is defined as the change in a subject's ADHD Rating Scale total score in the Efficacy Population at Visit 6 (Day 28) compared to baseline (ADHD-RS total score). The baseline (Visit 2) data will be obtained prior to the first administration of study drug.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corium, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier Research, Prometrika, LLC, Almac
- Responsible party
- Sponsor
- Investigators
- Ann Childress, MD, Principal investigator, Center for Psychiatry And Behavioral Medicine Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685732
- Sponsor's protocol ID
- KP415.P01
- Acronym
- KP415P01
- Status last verified
- May 2025
- First submitted
- 13 Dec 2022
- Last updated
- 13 May 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 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Dose-Optimized, Randomized, Double Blind, Efficacy and Safety Study With Azstarys® in Children 4 to 12 Years of Age With Attention Deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT05685732
- Acronym / sponsor ID
- KP415P01 / KP415.P01
- Conditions
- Attention Deficit/Hyperactivity Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Corium, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Premier Research, Prometrika, LLC, Almac
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 17 Jan 2023 (actual)
- Results
- Posted 13 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, dose-optimized, randomized, double-blind, placebo controlled, efficacy and safety study with Azstarys® in children 4 to 12 years of age with attention-deficit/hyperactivity disorder (ADHD). Azstarys® contains dexmethylphenidate (d-MPH) and serdexmethylphenidate (SDX), a prodrug of d-MPH and is orally administered. The primary objective is to determine the efficacy of Azstarys® compared to placebo in treating children ages 4 to 12 years old with ADHD. The study will consist of two randomized and blinded treatment cohorts ages 4 to 5 years of age and 6 to 12 years of age. Randomization will be applied separately with a starting dose up-titration at different dose levels for each cohort. 130 and 100 subjects will be enrolled, respectively. Approximately 20 sites will participate.
Detailed description
- Screening Period (Visit 1) Subjects will undergo a screening period up to 30 days prior to entering the Treatment Period.
- Double-Blind Treatment Period (Visit 2 through Visit 6, approx. 28 days) Eligible subjects will be randomized in a blinded fashion to Azstarys® or placebo at the start of the Treatment Period. Randomization will be applied separately in each cohort and stratified by gender.
- Cohort 1: Subjects 4 and 5 years (<6 years) will start at 13.1 mg/2.6 mg or matching placebo and may be titrated up or down to doses of 13.1 mg/2.6 mg, 26.1 mg/5.2 mg, or 39.2 mg/7.8 mg Azstarys® or matching placebo approximately each week through Visit 5 (Day 21)
- Cohort 2: Subjects 6-12 years (<13 years) will start at 39.2 mg/7.8 mg or matching placebo and may be titrated up or down to doses of 26.1 mg/5.2 mg, 39.2 mg/7.8 mg, or 52.3 mg/10.4 mg Azstarys® or matching placebo approximately each week through Visit 5 (Day 21) Subjects who participate in Cohort 1 and successfully complete the Treatment Period will have the option to participate in a 12-month open-label safety study with Azstarys®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- The primary endpoint is defined as the change in a subject's ADHD Rating Scale total score in the Efficacy Population at Visit 6 (Day 28) compared to baseline (ADHD-RS total score). The baseline (Visit 2) data will be obtained prior to the first administration of study drug.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: SDX/d-MPH in 4-5 year old | Experimental | Drug: Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)13.1 mg/2.6 mg SDX/d-MPH, 26.1 mg/5.2 mg SDX/d-MPH, 39.2 mg/7.8 mg SDX/d-MPH |
| Cohort 1: Placebo in 4-5 year old | Placebo comparator | Other: placebomatching placebo |
| Cohort 2: SDX/d-MPH in 6-12 year old | Experimental | Drug: Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)26.1 mg/5.2 mg SDX/d-MPH, 39.2 mg/7.8 mg SDX/d-MPH, 52.3 mg/10.4 mg SDX/d-MPH |
| Cohort 2: Placebo in 6-12 year old | Placebo comparator | Other: placebomatching placebo |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- In Cohort 1, subjects must be at least 4 years old and less than 5 years and 10 months at Screening; in Cohort 2, subjects must be at least 6 years old and less than 12 years and 10 months at Screening.
- Subjects must have a body weight within the 5th and 95th percentile according to the gender-specific weight-for-age percentile charts from the Centers for Disease Control and Prevention (CDC). See calculator at https://www.infantchart.com/child/.
- Female subjects must agree, if they are of childbearing potential at Screening or when they become of childbearing potential during the study, to remain abstinent or agree to use an effective and medically acceptable form of birth control from the time of written or verbal assent to at least 14 days after the last dose of study drug. Childbearing potential is defined as follows: Girls under the age of 12 who have not had their first period will be considered "not of child-bearing potential." Girls 12 years of age (including girls who will become 13 years during the study) will be considered "of child-bearing potential," even if they have not yet had their first period. Irrespective of age, girls who have had their first period, will be considered "of child-bearing potential."
- Subjects must be in general good health defined as the absence of any clinically relevant abnormalities as determined by the Investigator based on physical examinations, vital signs, electrocardiograms (ECGs), medical history, and clinical laboratory values (chemistry, hematology, urinalysis) at Screening. If any of the chemistry or hematology tests are not within the laboratory's reference range, then the subject can be included only if the Investigator determines the deviations to be not clinically relevant.
- At least one parent/legal guardian of the subject must voluntarily give written permission for him/her to participate in the study.
Key exclusion criteria (27 listed)
- If female, must not be pregnant or breastfeeding, and if of childbearing potential, must have a negative urine pregnancy test at the start of the Screening Period. In addition, a positive pregnancy test before the last dose of study drug will result in early termination from the study.
- Subject with any clinically significant chronic medical condition that, in the judgment of the Investigator, may interfere with the participant's ability to participate in the study.
- Subject has any diagnosis of bipolar I or II disorder, major depressive disorder, conduct disorder, obsessive-compulsive disorder, any history of psychosis, autism spectrum disorder, disruptive mood dysregulation disorder (DMDD), intellectual disability, Tourette's Syndrome, confirmed genetic disorder with cognitive and/or behavioral disturbances. Subjects with oppositional defiant disorder (ODD) are permitted to enroll in the study as long as ODD is not the primary focus of treatment, and, in the opinion of the Investigator, the ODD is mild to moderate, and eligible subjects with ODD are appropriate and cooperative during Screening.
- Subject has generalized anxiety disorder or panic disorder that has been the primary focus of treatment at any time during the 12 months prior to Screening or that has required pharmacotherapy any time during the 6 months prior to Screening.
- Subject has evidence of any chronic disease of the central nervous system (CNS) such as tumors, inflammation, seizure disorder, depression, vascular disorder, potential CNS-related disorders that might occur in childhood (e.g., Duchenne Muscular dystrophy, myasthenia gravis, or other neurologic or serious neuromuscular disorders), or history of persistent neurological symptoms attributable to serious head injury.
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 |
|---|---|---|
| Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH) | Drug | Cohort 1: SDX/d-MPH in 4-5 year old, Cohort 2: SDX/d-MPH in 6-12 year old |
| placebomatching placebo | Other | Cohort 1: Placebo in 4-5 year old, Cohort 2: Placebo in 6-12 year old |
Primary outcome
A Comparison of the Change in Mean ADHD Rating Scale (ADHD-RS) Results From Baseline to End of Treatment Between Active and Placebo Treatments.
Time frame: 4 weeks
The ADHD-RS is an 18-item scale based on Diagnostic and Statistical Manual of Mental Disorders criteria of ADHD that rates symptoms on a 4-point scale. Each item is scored using a combination of severity and frequency ratings from a range of 0 (reflecting no symptoms or a frequency of never or rarely) to 3 (reflecting severe symptoms or a frequency of very often), so that the total ADHD-RS scores range from 0 to 54. Scores will be obtained during a clinician-directed interview with the parent/guardian/caregiver at each visit.
2 secondary outcomes
A Comparison of the Change in Mean Clinical Global Impressions-Severity (CGI-S) Results From Baseline to End of Treatment Between Active and Placebo Treatments.
Time frame: 4 weeks
A Comparison of the Change in Mean Clinical Global Impressions-Improvement (CGI-I) Results From Visit 3 to End of Treatment Between Active and Placebo Treatments.
Time frame: 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 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.
Ann Childress, MD principal investigator
Center for Psychiatry And Behavioral Medicine Inc.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH) in people with Attention Deficit/Hyperactivity Disorder, run by Corium, Inc. at 20 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 15 inclusion and 27 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 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 13 May 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?
A Comparison of the Change in Mean ADHD Rating Scale (ADHD-RS) Results From Baseline to End of Treatment Between Active and Placebo Treatments. (time frame: 4 weeks). 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 13 May 2025.