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ADHDPhase 3NCT06359899

A Study to Evaluate the Efficacy, Safety and Tolerability of Oral AK0901 in Children With ADHD

A Phase 3 study testing AK0901 capsule in people with ADHD, run by Shanghai Ark Biopharmaceutical Co., Ltd. at 2 sites in China.

Completed

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

Official record
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Trial summary

This study is a Phase 3, multicenter, dose-optimized, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy, safety, and tolerability of oral AK0901 capsules in children 6 to 12 years old with Attention Deficit Hyperactivity Disorder（ADHD）. Read more about this study

Who is it for?
Ages 6 to 12 years
Conditions the study is for
ADHD
What is being tested?
AK0901 capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
55 participants
Where
2 sitesChina
Study dates
28 May 2024to 11 Jan 2025
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

  • At the time of signing informed consent form, subjects must be between 6 and 12 years of age (inclusive) and of any gender.
  • Subjects meet the diagnostic criteria for ADHD (attention deficit or hyperactivityj/impulsivity or combined attention deficit and hyperactivity/impulsivity manifestations) in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) as medically evaluated and confirmed by the Chinese version of Kiddie-schedule for affective disorders and schizophrenia-present and lifetime version DSM-5 (K-SADS-PL-C DSM-5).
  • An ADHD-RS-5 total score of at least 28. For subjects requiring washout of ADHD medications, this criterion refers to a score following washout.
  • A score of at least 3 (mildly ill) on the Clinical Global Impressions - Severity (CGI-S) scale as assessed by clinician. For subjects requiring washout of ADHD medications, this criterion refers to a score following washout.
  • Weight exceeds the median weight for the appropriate age and sex minus two times the standard deviation (2SD) .
  • Able to sign the ICF, including compliance with the requirements and limitations specified in the ICF and this protocol.
  • Understand the importance of adhering to study medication requirements and completing all assessments on time throughout the study, and agree to strictly follow the requirements as specified in the protocol, including restrictions on concomitant medications during the study.
  • The subject's parent/legal guardian must ensure that the subject: has washed out ongoing stimulants for ADHD and herbal/Chinese patent medicines for the treatment of ADHD 5 days prior to the first dose and is abstained from these medications until the end of the study or early termination of the study; and must wash out ongoing non-stimulants for ADHD 14 days prior to the first dose and is abstained from these medications until the end of the study or early termination of the study.

Who cannot join

  • Medical disorders
  • Pre-existing or current clinically significant disease or any condition that, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of study results, or would result in the subject's inability to complete study in accordance with the protocol.
  • Presence of evidence of central nervous system (CNS) diseases (e.g., tumor, inflammation, epilepsy, vascular disease), or neuromuscular disorder that may have occurred in childhood (e.g., Duchenne muscular dystrophy, myasthenia gravis), or history of persistent neurological symptoms that can be attributed to severe head injury, or other serious nervous system disorders. Simple febrile seizure is allowed. Patients with electroencephalogram suggesting epileptiform discharge or seizure susceptibility will be excluded.
  • History of mental illness including, but not limited to, a diagnosis of bipolar disorder, major depressive disorder, conduct disorder, obsessive-compulsive disorder, childhood schizophrenia, autism spectrum disorder, disruptive mood dysregulation disorder (DMDD), intellectual developmental disorder, tic disorders, generalized anxiety disorder or panic disorder, severe sleep disorder, and genetic disorders associated with cognitive and/or behavioral disorder. Oppositional defiant disorder (ODD) is permitted if the condition is mild-moderate, not a current treatment priority, and the investigator assesses that the subject is appropriate and cooperative.
  • Subject has any history of attempted suicide or clinically significant suicidal ideation based on the Columbia-Suicide Severity Rating Scale (C-SSRS) assessment, in the opinion of the investigator, at screening or Day 1.
  • Cardiovascular system , digestive system , endocrine system, ophthalmology , respiratory system, and hepatic or renal system, or any other clinically significant concomitant diseases that could jeopardize the safety of the subject or affect the results of the study.
Show all 31Show fewer
  • Active malignancy and/or history of malignancy.
  • History of allergy or suspected allergy to methylphenidate, serdexmethylphenidate, or AK0901 excipients.
  • History of serious allergy to any drug, or known history of allergy to more than one drug.
  • Previous therapies/concomitant treatment
  • Have received or are receiving systematic cognitive behavioral therapy (CBT), behavioral therapy, or other non-drug therapies for ADHD within 1 month 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 exceptional at the discretion of the investigator.
  • Subjects with lack of response or intolerability to previous adequate dose and duration of treatment with methylphenidate products in the opinion of the investigator.
  • Use of monoamine oxidase inhibitors within 14 days prior to the first dose; use of the following medications within 21 days prior to the first dose: antidepressants, mood stabilizers, antipsychotics, coumarin anticoagulants, anticonvulsants, halogenated anesthetics, phenylbutazone, and sedative hypnotics.
  • Planned use of prohibited drugs or non-drug therapies as specified in the protocol during the study.
  • Clinical study experience of prior/concomitant medications
  • Subject has participated in clinical study of any other investigational product within 90 days or 5 half-lives, whichever is longer, prior to screening, or is currently participating in another drug clinical trial.
  • Diagnostic assessments
  • At the discretion of the investigator, has a clinically significant abnormal finding in the physical examination, neurological examination, vital signs, ECG, or clinical laboratory tests at screening.
  • Mean systolic or diastolic blood pressure measurements ≥ 95th percentile for corresponding age, gender, and height at screening or Day 1.
  • Electrocardiogram shows QTcF interval ≥ 450 ms at screening [QTcF = QT/(RR^0.33)].
  • Glutamic-pyruvate transaminase (SGPT) or glutamic-oxaloacetic transferase (SGOT) ≥ 1.5 × the upper limit of normal (ULN) or blood creatinine > ULN at screening.
  • Thyroid stimulating hormone (TSH), free thyroxine (FT4), or free tri-iodothyronine (FT3) abnormality at screening.
  • Other exclusion criteria
  • Subjects with a history of drug or alcohol abuse within 1 year prior to screening; positive alcohol or drug screen at screening or Day 1 ;
  • Positive screening for methylphenidate at screening or Day 1.
  • Use of tobacco or other nicotine-containing products at screening.
  • Family history (parents and siblings) of sudden cardiac death, severe ventricular arrhythmia, or QT prolongation.
  • The subject's parent/legal guardian is an investigator of this study, employee of the study site with direct involvement in this study or any other studies under the direction of the investigator, sponsor's employee, or any family members of the investigator of this study, employee of study site or sponsor's employee.
  • Subject and parent/legal guardian are unable to communicate well with the investigator.
  • Any other reason that, in the opinion of the investigator, would make subject's participation inappropriate.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Beijing anding hospital capital medical university

    Beijing, Beijing Municipality

  • Peking university sixth hospital

    Beijing, Beijing Municipality

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Investigate the Efficacy, Safety and Tolerability of Oral Administered AK0901 Capsules in Children Aged 6-12 Years Old With Attention Deficit Hyperactivity Disorder

This study is a Phase 3, multicenter, dose-optimized, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy, safety, and tolerability of oral AK0901 capsules in children 6 to 12 years old with Attention Deficit Hyperactivity Disorder（ADHD）.

Read the detailed description

The study consists of an approximately 28-day screening period, a 28-day double-blind treatment period, and a follow-up period for 5±2 days.

During the screening period, all subjects must sign an informed consent form and complete all assessment items at the screening visit prior to the screening. Study drug is started within 28 days of signing the informed consent form.

During the double-blind treatment period, all eligible subjects are randomized 1:1 to receive AK0901 or placebo once daily for 4 weeks. During the first week, all subjects are given a starting dose of 39.2 mg/7.8 mg AK0901 or matching placebo; from the second week, the dose drug can be increased or decreased, or maintained at the original dose level at weekly follow-up depending on tolerability and optimal individual dose response at the investigator's discretion.

After the last dose in the double-blind treatment period, subjects will enter a 5 ± 2 day follow-up period for safety assessments. The primary analysis will be performed after all subjects have completed the study.

Conditions
ADHD
Being tested
AK0901 capsule, 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.

  • AK0901 capsuleDrug

    Also called AZSTARYS (SDX/d-MPH capsules)

    Active Substance: AK0901, Pharmaceutical Form: Capsule, Route of Administration: Oral

  • PlaceboDrug

    Active Substance: Placebo, Pharmaceutical Form: Capsule, Route of Administration: Oral

Study groups in NCT06359899
Study groupRoleWhat they receive
AK0901 cohortExperimental13.1 mg/2.6 mg AK0901, 26.1 mg/5.2 mg AK0901, 39.2 mg/7.8 mg AK0901
Receives: Drug: AK0901 capsule
Placebo cohortPlacebo comparatorMatching placebo
Receives: Drug: Placebo

What is being measured

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

  1. To evaluate the efficacy of AK0901 compared to placebo in children 6 to 12 years old with ADHD.

    Change from baseline in ADHD-RS-5* total score at Week 3. Attention-Deficit Hyperactivity Disorder Rating Scale 5 is a scale containing 18 symptomatic entries with each entry scored on a 4-point scale. Each entry is scored using a frequency assessment from 0 (symptom never or rarely) to 3 (symptom very frequent), with a total score ranging from 0 to 54.

    A decreasing value of the total score represents a clinical improvement. Unless otherwise noted, the last non-missing measurement/assessment before the first dose of the investigational product is defined as the Baseline measurement. If a measurement/evaluation is performed on the same day of the first dose of the investigational product, these measurements will be considered as Baselines.

    Measured: From Baseline (Pre-dose on Day 1) to week 3

Secondary outcomes (19)

  1. Change from baseline in ADHD-RS-5 total score at Week 4.

    Attention-Deficit Hyperactivity Disorder Rating Scale 5 is a scale containing 18 symptomatic entries with each entry scored on a 4-point scale. Each entry is scored using a frequency assessment from 0 (symptom never or rarely) to 3 (symptom very frequent), with a total score ranging from 0 to 54.

    A decreasing value of the total score represents a clinical improvement. Unless otherwise noted, the last non-missing measurement/assessment before the first dose of the investigational product is defined as the Baseline measurement. If a measurement/evaluation is performed on the same day of the first dose of the investigational product, these measurements will be considered as Baselines.

    Measured: From Baseline (Pre-dose on Day 1) to week 4

  2. Changes in ADHD-RS-5 inattention subscale score from baseline to each visit in the Double-Blind Treatment Period

    Attention-Deficit Hyperactivity Disorder Rating Scale 5 is a scale containing 18 symptomatic entries with each entry scored on a 4-point scale. Each entry is scored using a frequency assessment from 0 (symptom never or rarely) to 3 (symptom very frequent), with a total score ranging from 0 to 54.The 18 entries in the ADHD-RS-5 can be divided into two 9-item subscales, one to assess impulsivity-hyperactivity and the other to assess attention deficits.A decreasing value of the total score represents a clinical improvement.

    Measured: From Baseline (Pre-dose on Day 1) to week 4

  3. Changes in ADHD-RS-5 hyperactivity/impulsivity subscale score from baseline to each visit in the Double-Blind Treatment Period.

    Attention-Deficit Hyperactivity Disorder Rating Scale 5 is a scale containing 18 symptomatic entries with each entry scored on a 4-point scale. Each entry is scored using a frequency assessment from 0 (symptom never or rarely) to 3 (symptom very frequent), with a total score ranging from 0 to 54.The 18 entries in the ADHD-RS-5 can be divided into two 9-item subscales, one to assess impulsivity-hyperactivity and the other to assess attention deficits.A decreasing value of the total score represents a clinical improvement.

    Measured: From Baseline (Pre-dose on Day 1) to week 4

  4. Change in CGI-S score from baseline to each visit in the Double-Blind Treatment Period

    Clinical Global Impressions - Severity is a clinical rating scale used to assess the severity of psychopathology (ADHD symptoms in this study) on a scale from 1 to 7.A decreasing value of the score represents a clinical improvement.

    Measured: From Baseline (Pre-dose on Day 1) to week 4

  5. CGI-I scores from V3 at each visit in the Double-Blind Treatment Period

    Clinical Global Impressions - Improvement is a clinical rating scale used to assess the degree of improvement in psychopathology (ADHD symptoms in this study) on a scale from 1 to 7. A decreasing value of the score represents a clinical improvement.

    Measured: From V3 (week 1) to week 4

  6. Change in WREMB-R score from baseline to each visit in the Double-Blind Treatment

    Weekly Rating of Evening and Morning Behavior - Revised is an 11-entry questionnaire to assess behavioral severity in the morning (3 entries) and evening (8 entries). Scores for each entry range from 0 to 3. A decreasing value of the total score represents a clinical improvement.

    Measured: From Baseline to week 4

  7. Proportion of subjects with adverse events (AEs) occurring during the study

    To evaluate the safety and tolerability of AK0901.

    Measured: From Baseline to Day 33

  8. Proportion of subjects with serious adverse events (SAEs) occurring during the study

    To evaluate the safety and tolerability of AK0901.

    Measured: From Baseline to Day 33

  9. Changes in respiratory rate during the study

    To explore the difference in respiratory rate (bpm) with clinical significance between subjects on AK0901 and those on placebo.

    Measured: From Baseline to Day 33

  10. Changes in heart rate during the study

    To explore the difference in heart rate/pulse (bpm) with clinical significance between subjects on AK0901 and those on placebo.

    Measured: From Baseline to Day 33

  11. Changes in body temperature during the study

    To explore the difference in body temperature (Celsius) with clinical significance between subjects on AK0901 and those on placebo.

    Measured: From Baseline to Day 33

  12. Changes in systolic blood pressure during the study

    To explore the difference in systolic blood pressure (mmHg) with clinical significance between subjects on AK0901 and those on placebo.

    Measured: From Baseline to Day 33

  13. Changes in diastolic blood pressure during the study

    To explore the difference in diastolic blood pressure (mmHg) with clinical significance between subjects on AK0901 and those on placebo.

    Measured: From Baseline to Day 33

  14. Change from baseline in QT intervals from resting EKGs

    EKGs will be performed after the subject has been supine for at least 3 minutes

    Measured: Screen/day -1/day1/day14/day28/day33

  15. Change from baseline in QTcF intervals from resting EKGs

    EKGs will be performed after the subject has been supine for at least 3 minutes

    Measured: Screen/day -1/day1/day14/day28/day33

  16. Change from baseline in heart rate resting EKGs

    EKGs will be performed after the subject has been supine for at least 3 minutes

    Measured: Screen/day -1/day1/day14/day28/day33

  17. Change from baseline in QRS intervals from resting EKGs

    EKGs will be performed after the subject has been supine for at least 3 minutes

    Measured: Screen/day -1/day1/day14/day28/day33

  18. Change from baseline in PR intervals from resting EKGs

    EKGs will be performed after the subject has been supine for at least 3 minutes

    Measured: Screen/day -1/day1/day14/day28/day33

  19. Change in CSHQ score from baseline to each visit in the Double-Blind Treatment Period

    Children's Sleep Habits Questionnaire is a retrospective questionnaire containing 33 entries to examine sleep behavior in children. Entries in the key sleep domain are scored on a 3-point scale.A decreasing value of the total score represents a clinical improvement.

    Measured: From Baseline to Day 33

Timeline

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

  1. First posted11 Apr 2024
  2. Study start28 May 2024
  3. Primary completion6 Jan 2025
  4. Study completion11 Jan 2025

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06359899
Sponsor's protocol ID
AK0901-2001
Status last verified
Jun 2026
First submitted
25 Mar 2024
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Liu J, Yang Y, Wang Y, Chen J, Yang R, Cui Y, Zhang L, Liu W, He F, Yang L, Xu D, Sun J, Aisikeer A, Fan X, Liu J, Wang L, Sun Z, Jia T, Qi J, Wu JZ, Zheng Y. A Phase 3, Multicenter, Randomized, Placebo-Controlled Trial Evaluating the Efficacy, Safety, and Tolerability of Serdexmethylphenidate/d-Methylphenidate Capsules in Chinese Children with Attention-Deficit/Hyperactivity Disorder. CNS Drugs. 2026 Oct 4. doi: 10.1007/s40263-026-01341-5. Online ahead of print.

    PubMed 42830387

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AK0901 capsule in people with ADHD, run by Shanghai Ark Biopharmaceutical Co., Ltd. at 2 sites in China.

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 8 inclusion and 31 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 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To evaluate the efficacy of AK0901 compared to placebo in children 6 to 12 years old with ADHD. (time frame: From Baseline (Pre-dose on Day 1) to week 3). 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 NCT06359899, which also lists 1 linked publication.

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 22 Jun 2026.

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