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

NCT06359899 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: AK0901-2001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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）.

Conditions

ADHD

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (19)

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

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

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

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

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

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

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

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

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

  From V3 (week 1) to week 4

Study Arms (2)

AK0901 cohort

EXPERIMENTAL

13.1 mg/2.6 mg AK0901, 26.1 mg/5.2 mg AK0901, 39.2 mg/7.8 mg AK0901

Drug: AK0901 capsule

Placebo cohort

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

AK0901 capsule DRUG

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

Also known as: AZSTARYS (SDX/d-MPH capsules)

AK0901 cohort

Placebo DRUG

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

Placebo cohort

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shanghai Ark Biopharmaceutical Co., Ltd.: lead

Study Sites (2)

Beijing anding hospital capital medical university

Beijing, Beijing Municipality, China

Location

Peking university sixth hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

serdexmethylphenidate and dexmethylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Jingjing Hu

  Clinical Operation Head

  STUDY CHAIR

• Jun Qi

  Medicial Director

  STUDY DIRECTOR

Central Study Contacts

Yang Liu

CONTACT

86-18796252038; yang.liu@arkbiosciences.com

Jiayi Mai

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 11, 2024
• Study Start: May 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: April 11, 2024

Record last verified: 2024-03

Locations

CN (2)