Azstarys® for ADHD

(KP415P02 Trial)

Recruiting at 21 trial locations

Overseen By Charles Oh, MD

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Corium, Inc.

Must not be taking: Anticonvulsants, others

Disqualifiers: Bipolar, Major depression, Autism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

123 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

Yes, participants must stop taking their current stimulant ADHD medications 5 days before starting the trial and non-stimulant ADHD medications 14 days before starting. They must not take these medications during the trial.

What data supports the effectiveness of the drug Azstarys® for ADHD?

Research shows that Azstarys®, which combines serdexmethylphenidate and dexmethylphenidate, significantly improves ADHD symptoms in children compared to a placebo, with effects lasting from 1 to 10 hours after taking the drug. It was also found to be safe and well-tolerated over a 12-month period, with improvements in ADHD symptoms sustained throughout the year. ^{1 2 3 4 5}

Is Azstarys® (Serdexmethylphenidate/Dexmethylphenidate) safe for children with ADHD?

Azstarys® has been studied for safety in children with ADHD and is generally well tolerated, with common side effects including decreased appetite and sleep issues. Serious side effects were rare, and the treatment did not show significant negative effects on heart health or growth over a year. ^{1 2 3 6 7}

How is the drug Azstarys® unique for treating ADHD?

Azstarys® is unique because it combines serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH) to provide a rapid onset and extended duration of effect, improving ADHD symptoms in children for up to 13 hours with once-daily dosing. ^{1 2 3 8 9}

Research Team

Ann Childress, M.D.

Principal Investigator

Center for Psychiatry And Behavioral Medicine Inc.

Eligibility Criteria

This trial is for children aged 4 to less than 5 years and 10 months with ADHD who are in good health, have had symptoms for at least 6 months, and meet specific criteria including a certain body weight range. They must not be on current ADHD medication or start psychotherapy during the trial. Children with uncontrolled thyroid disorders, severe allergies to methylphenidate, or significant medical conditions are excluded.

Inclusion Criteria

I am in good health with no significant medical issues.

My weight is within the normal range for my age and gender according to CDC charts.

You must be diagnosed with ADHD by a doctor using specific criteria and confirmed by a special interview for children and adolescents.

Exclusion Criteria

Subject has a history or presence of abnormal ECGs, which in the Investigator's opinion is clinically significant.

A current or recent (past 12 months) history of drug abuse in someone living in the subjects' home.

I plan to start or continue psychotherapy during the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Dose Optimization

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

3 weeks

Treatment

Eligible subjects will receive single daily doses of Azstarys® for approximately 12 months. The daily dose may be changed at any time to any of the allowed dose levels based on individual tolerability and dose response

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)

Trial Overview The study tests Azstarys®, which contains Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH), in young children with ADHD over up to 12 months. It aims to determine safety/tolerability and understand how the drug moves through the body (pharmacokinetics). Around 100 participants will join across approximately 20 sites.

Participant Groups

Group I: Open Label Experimental Treatment 1 Intervention

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 Is Running the Clinical Trial?

Corium, Inc.

Lead Sponsor

Trials

9

Recruited

1,000+

Almac

Industry Sponsor

Trials

4

Recruited

490+

Worldwide Clinical Trials

Collaborator

Trials

70

Recruited

15,800+

Almac

Collaborator

Trials

4

Recruited

490+

Premier Research Group plc

Industry Sponsor

Trials

65

Recruited

74,200+

John Ratliff

Premier Research Group plc

Chief Executive Officer since 2024

MBA

Dr. Milena Kanova-Petrova

Premier Research Group plc

Chief Medical Officer since 2024

MD

Prometrika, LLC

Collaborator

Trials

4

Recruited

400+

Findings from Research

In a 1-year study involving 282 children aged 6-12 with ADHD, SDX/d-MPH was found to be safe and well tolerated, with 60.1% of participants experiencing treatment-emergent adverse events, mostly mild to moderate.

The treatment led to significant reductions in ADHD symptoms, demonstrating sustained efficacy over the year, comparable to other methylphenidate products, with no unexpected safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Tolerability of Serdexmethylphenidate/Dexmethylphenidate Capsules in Children with Attention-Deficit/Hyperactivity Disorder: A 12-Month, Open-Label Safety Study. Childress, AC., Marraffino, A., Cutler, AJ., et al.[2023]

In a study involving 149 children aged 6-12 with ADHD, the once-daily medication SDX/d-MPH significantly improved ADHD symptoms compared to placebo, showing a rapid onset and extended duration of efficacy.

The treatment was found to be safe, with no serious adverse events reported, although common side effects included insomnia and decreased appetite, similar to those seen with other stimulant medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized, Controlled Laboratory Classroom Study of Serdexmethylphenidate and d-Methylphenidate Capsules in Children with Attention-Deficit/Hyperactivity Disorder. Kollins, SH., Braeckman, R., Guenther, S., et al.[2021]

Serdexmethylphenidate (SDX) is a newly approved treatment for ADHD that offers a longer duration of action compared to other stimulant medications, making it a promising option for patients.

Early studies indicate that SDX is safe and has side effects similar to other stimulants, while its prodrug design may help reduce the risk of abuse and allows for flexible administration for those who have difficulty swallowing pills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating serdexmethylphenidate and dexmethylphenidate capsules as a once-daily treatment option for ADHD. Barnhardt, EA., Narayanan, AR., Coury, DL.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Safety and Tolerability of Serdexmethylphenidate/Dexmethylphenidate Capsules in Children with Attention-Deficit/Hyperactivity Disorder: A 12-Month, Open-Label Safety Study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

A Randomized, Controlled Laboratory Classroom Study of Serdexmethylphenidate and d-Methylphenidate Capsules in Children with Attention-Deficit/Hyperactivity Disorder. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Analysis of Growth Velocity in Children with Attention-Deficit/Hyperactivity Disorder Treated for up to 12 Months with Serdexmethylphenidate/Dexmethylphenidate. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Evaluating serdexmethylphenidate and dexmethylphenidate capsules as a once-daily treatment option for ADHD. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Side effects of methylphenidate and dexamphetamine in children with attention deficit hyperactivity disorder: a double-blind, crossover trial. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Serdexmethylphenidate/dexmethylphenidate effects on sleep in children with attention-deficit/hyperactivity disorder. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Oral, intranasal, and intravenous abuse potential of serdexmethylphenidate, a novel prodrug of d-methylphenidate. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Comparative efficacy, acceptability, and tolerability of dexmethylphenidate versus placebo in child and adolescent ADHD: a meta-analysis of randomized controlled trials. [2020]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Dexmethylphenidate. [2018]