Attention Deficit/Hyperactivity DisorderPhase 4KP415P02NCT05721235

A Safety/Tolerability and PK Study With Azstarys® in Children 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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 4 to 5 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?: No, everyone receives an active treatment
How many people: 123 participants
Where: 20 sitesUnited States
Study dates: 2 Jun 2023to 31 Jul 2025
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 5 years
All sexes
No healthy volunteers
Child

Who may be able to join

New Subjects must be at least 4 years old and less than 5 years and 10 months old 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).
Subject 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, ECGs, medical history, and clinical laboratory values (chemistry, hematology and urinalysis) at Screening.
At least one parent/legal guardian of the subject must voluntarily give written permission for the subject to participate in the study.
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 the Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI Kid).
Subject must have had ADHD symptoms present for at least 6 months prior to the Screening Visit.

Show all 13Show fewer

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 Dose Optimization Phase, and abstain from taking these to the end of the Treatment Phase (Visit 17) or Early Termination (ET); and wash out non-stimulant ADHD medications from 14 days prior to the start of the Dose Optimization Phase, and abstain from taking these to the end of the Treatment Phase (Visit 17) or ET.
Subject must have a score of ≥4 (Moderately Ill) on the clinician-administered Clinical Global Impressions-Severity (CGI-S) scale.
Subject functions at an age-appropriate level intellectually, as determined by the Investigator.
Subject must have age and sex adjusted ratings of ≥90th percentile Total Score on the ADHD-RS-IV (Preschool Version) rated over the past 6 months.
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'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's 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

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.
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, 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 currently or within the past 2 years before Screening are not eligible for study participation.
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.

Show all 26Show fewer

In the opinion of the Investigator, subject has clinically significant suicidal ideation/behavior, based on history of attempted suicide and the 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 drug absorption, distribution, metabolism, or excretion of study drug.
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 on the urinalysis at Screening.
A current or recent (past 12 months) history of drug abuse in someone living in the subjects' home.
Subject has a positive urine screen for drugs of abuse at Screening. If the urine test is positive for any of the analytes at Screening, the subject will be excluded from study participation, with the exception of the following: Depending on a subject's current ADHD medication at Screening, the urine screen may test positive for MPH for treatment of their ADHD.
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, except for participation in Study KP415.P01.
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.
Subject has demonstrated lack of response or intolerability to adequate dose and duration of treatment with methylphenidate products.
Subject is using or planning to use prohibited drugs during the trial as specified in the protocol.
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 methylphenidate 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 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.

City, postcode or hospital

20 sites in 1 country

United States20 sites

Advanced Research Center (ARC)
Anaheim, California, 92805
Houston Clinical Trials
Bellaire, Texas, 77401
IMMUNOe International Research Center
Centennial, Colorado, 80112
iResearch Atlanta
Decatur, Georgia, 30030
Clinical Neuroscience Solutions - Orlando
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 Solution, Inc
Memphis, Tennessee, 38119
South Florida Research Phase I-IV INC
Miami Springs, Florida, 33166
Boeson Research
Missoula, Montana, 59804
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, 63304
Flourish Research
San Antonio, Texas, 78229
CenExel iResearch, LLC
Savannah, Georgia, 31405
Sky Clinical Research Network Group P.C.
Union City, Georgia, 30291

Other trials in United States

About this study

Official title: A Multicenter, Dose-Optimized, Open-Label, Safety/Tolerability and Pharmacokinetic Study With Azstarys® in Children 4 and 5 Years of Age With Attention-Deficit/Hyperactivity Disorder

The is a multicenter, dose-optimized, open-label, safety/ tolerability and pharmacokinetic (PK) study with Azstarys® in children 4 and 5 years of age with attention-deficit/hyperactivity disorder (ADHD). The primary objective is to determine the safety and tolerability of treating children 4 and 5 years-of-age with ADHD with Azstarys® for up 12 months. Approximately 100 subjects will be enrolled. Approximately 20 sites will participate.

Read the detailed description

Screening Period: New subjects will undergo a Screening Period up to 30 days prior to entering the Dose Optimization Phase.
Dose Optimization Phase: During the 3-week Dose Optimization Phase, subjects will start at 13.1 mg/2.6 mg, and may be titrated to doses of 26.1 mg/5.2 mg or 39.2 mg/7.8 mg Azstarys® capsules based on individual tolerability and best dose-response in the opinion of the Investigator.
Treatment Phase: Eligible subjects will receive single daily doses of Azstarys® for approximately 360 ±20 days (approximately 12 months). The starting dose of Azstarys® in the Treatment Phase will be the same as the optimized dose of Azstarys® at the end of the Dose Optimization Phase, either 13.1 mg/2.6 mg, 26.1/5.2 mg, or 39.2 mg/7.8 mg per day. The daily dose may be changed at any time to any of the allowed dose levels (13.1 mg/2.6 mg, 26.1/5.2 mg, or 39.2 mg/7.8 mg per day) at the Investigator' discretion, based on individual tolerability and dose response.

Conditions: Attention Deficit/Hyperactivity Disorder
Being tested: Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)
Keywords: ADHD, Azstarys, Serdexmethylphenidate, Attention Deficit Hyperactvity Disorder
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)

Study groups in NCT05721235
Study group	Role	What they receive
Open Label	Experimental	13.1 mg/2.6 mg SDX/d-MPH, 26.1/5.2 mg SDX/d-MPH, or 39.2 mg/7.8 mg SDX/d-MPH Receives: Drug: Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)

What is being measured

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

Changes in Sleep Behavior
Summary of Change from Baseline in Children's Sleep Habits Questionnaire (CSHQ) Total Sleep Disturbance Score to End of Study. The CSHQ is a retrospective, 33-item parent questionnaire to examine sleep behavior in small children. Items are rated on a 3-point scale of "Usually", "Sometimes" and "Rarely" for occurrences in a number of key sleep domains (Bedtime Resistance, sleep onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep disordered breathing, and Daytime Sleepiness). The total Sleep Disturbance Score is the sum of the frequency ratings of the 33 items. The lowest possible score is 33 and the highest possible score is 99. Lower scores indicate improved sleep behavior, and a mean percentage decrease is considered an improvement.
Measured: 12 Months
Percent Change in Body Weight
Percent Change from Baseline in Body Weight (kg) During Treatment Phase in the Safety Population
Measured: 12 months
Percentile Change in Body Height
Percentile Change from Baseline (cm) During Treatment Phase
Measured: 12 Months
Percentile Change in Body Weight
Percentile Change from Baseline in Body Weight (kg) During Treatment Phase in the Safety Population
Measured: 12 months
Percent Change in Body Height
Percent Change from Baseline (cm) During Treatment Phase
Measured: 12 Months

Secondary outcomes (2)

Efficacy of ADHD Symptom Control Through Investigator Ratings on the ADHD-RS-IV
Determine efficacy with respect to the 12-month maintenance of ADHD symptom control through investigator ratings on the ADHD-RS-IV from baseline to 12 months. 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 (low score is better or shows improvement). Scores will be obtained during a clinician-directed interview with the parent/guardian/caregiver at each visit.
Measured: 12 months
Efficacy of CGI-S
Deterimine the efficacy of the CGI-S from baseline to 12 months. 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: 12 months

Timeline

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

2 Jun 202331 Jul 2025

First posted9 Feb 2023
Study start2 Jun 2023
Primary completion31 Jul 2025
Study completion31 Jul 2025

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: Not applicable
Intervention model: Single group
Model description: The primary objective is to determine the safety and tolerability for up to 12 months of treatment with Azstarys based on incidence of adverse events
Masking: None (open label)
Enrolment: 123 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05721235
Sponsor's protocol ID: KP415.P02
Acronym: KP415P02
Status last verified: May 2026
First submitted: 1 Feb 2023
Last updated: 8 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD

All Attention Deficit/Hyperactivity Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Dose-Optimized, Open-Label, Safety/Tolerability and Pharmacokinetic Study With Azstarys® in Children 4 and 5 Years of Age With Attention-Deficit/Hyperactivity Disorder
ClinicalTrials.gov ID: NCT05721235
Acronym / sponsor ID: KP415P02 / KP415.P02
Conditions: Attention Deficit/Hyperactivity Disorder
Keywords: ADHD, Azstarys, Serdexmethylphenidate, Attention Deficit Hyperactvity Disorder
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 123 participants (actual)
Lead sponsor: Corium, Inc.Industry (pharma, biotech, devices)
Collaborators: Premier Research, Prometrika, LLC, Almac, Worldwide Clinical Trials
Study start: 2 Jun 2023 (actual)
Primary completion: 31 Jul 2025 (actual)
Study completion: 31 Jul 2025 (actual)
First posted: 9 Feb 2023 (actual)
Results: Posted 8 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Screening Period: New subjects will undergo a Screening Period up to 30 days prior to entering the Dose Optimization Phase.
Dose Optimization Phase: During the 3-week Dose Optimization Phase, subjects will start at 13.1 mg/2.6 mg, and may be titrated to doses of 26.1 mg/5.2 mg or 39.2 mg/7.8 mg Azstarys® capsules based on individual tolerability and best dose-response in the opinion of the Investigator.
Treatment Phase: Eligible subjects will receive single daily doses of Azstarys® for approximately 360 ±20 days (approximately 12 months). The starting dose of Azstarys® in the Treatment Phase will be the same as the optimized dose of Azstarys® at the end of the Dose Optimization Phase, either 13.1 mg/2.6 mg, 26.1/5.2 mg, or 39.2 mg/7.8 mg per day. The daily dose may be changed at any time to any of the allowed dose levels (13.1 mg/2.6 mg, 26.1/5.2 mg, or 39.2 mg/7.8 mg per day) at the Investigator' discretion, based on individual tolerability and dose response.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: The primary objective is to determine the safety and tolerability for up to 12 months of treatment with Azstarys based on incidence of adverse events

Arm	Type	Receives
Open Label	Experimental	Drug: Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)13.1 mg/2.6 mg SDX/d-MPH, 26.1/5.2 mg SDX/d-MPH, or 39.2 mg/7.8 mg SDX/d-MPH

Who may qualify

Ages: 4 to 5 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (13 listed)

New Subjects must be at least 4 years old and less than 5 years and 10 months old 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).
Subject 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, ECGs, medical history, and clinical laboratory values (chemistry, hematology and urinalysis) at Screening.
At least one parent/legal guardian of the subject must voluntarily give written permission for the subject to participate in the study.
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 the Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI Kid).

Key exclusion criteria (26 listed)

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.
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, 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 currently or within the past 2 years before Screening are not eligible for study participation.

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	Open Label

Primary outcome

Changes in Sleep Behavior
Time frame: 12 Months
Summary of Change from Baseline in Children's Sleep Habits Questionnaire (CSHQ) Total Sleep Disturbance Score to End of Study. The CSHQ is a retrospective, 33-item parent questionnaire to examine sleep behavior in small children. Items are rated on a 3-point scale of "Usually", "Sometimes" and "Rarely" for occurrences in a number of key sleep domains (Bedtime Resistance, sleep onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep disordered breathing, and Daytime Sleepiness). The total Sleep Disturbance Score is the sum of the frequency ratings of the 33 items. The lowest possible score is 33 and the highest possible score is 99. Lower scores indicate improved sleep behavior, and a mean percentage decrease is considered an improvement.
Percent Change in Body Weight
Time frame: 12 months
Percent Change from Baseline in Body Weight (kg) During Treatment Phase in the Safety Population
Percentile Change in Body Height
Time frame: 12 Months
Percentile Change from Baseline (cm) During Treatment Phase
Percentile Change in Body Weight
Time frame: 12 months
Percentile Change from Baseline in Body Weight (kg) During Treatment Phase in the Safety Population
Percent Change in Body Height
Time frame: 12 Months
Percent Change from Baseline (cm) During Treatment Phase

2 secondary outcomes

Efficacy of ADHD Symptom Control Through Investigator Ratings on the ADHD-RS-IV
Time frame: 12 months
Efficacy of CGI-S
Time frame: 12 months

Results and safety

Results posted to the registry on 8 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Open Label	123	63

Primary outcome: Changes in Sleep Behavior

Time frame: 12 Months. Least squares mean (95% Confidence Interval). Unit: percentage score change

Measure	Open Label n = 95
Value	-6.5 (-8.0 to -5.0)

Population analysed: The Safety Analysis Population, as described per protocol, consists of 95 subjects

Primary outcome: Percent Change in Body Weight

Time frame: 12 months. Mean (Standard Deviation). Unit: Percent (%) Change of Body Weight

Measure	Open Label n = 95
Value	6.23 (8.162)

Population analysed: The Safety Analysis Population, as described per protocol, consists of 95 subjects

Primary outcome: Percentile Change in Body Height

Time frame: 12 Months. Mean (Standard Deviation). Unit: Percentile Change of Body Height

Measure	Open Label n = 95
Value	-10.77 (12.990)

Population analysed: The Safety Analysis Population, as described per protocol, consists of 95 subjects

Primary outcome: Percentile Change in Body Weight

Time frame: 12 months. Mean (Standard Deviation). Unit: Percentile Change of Body Weight

Measure	Open Label n = 95
Value	-15.68 (13.661)

Population analysed: The Safety Analysis Population, as described per protocol, consists of 95 subjects

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: The occurrence of treatment emergent adverse events (>/= 5%), by protocol definition, was assessed following the first dose of study drug in the Treatment Phase and ending five days after the last dose of study drug or early termination visit for the treatment phase population (N=95 subjects). This time period was 12 months. No deaths or SAEs were reported in this study among all enrolled subjects, including those who participated in the dose optimization phase only.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Open Label	0 of 95 (0%)	44 of 95 (46.3%)	0 of 95

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Attention Deficit/Hyperactivity Disorder

Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD

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 13 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: finished, as of the sponsor's last update on 8 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 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. 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 8 May 2026). 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?

Changes in Sleep Behavior (time frame: 12 Months). The study lists 5 primary outcomes in all. 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 NCT05721235.

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 8 May 2026.