246 Participants Needed

Azstarys® for ADHD

(KP415P01 Trial)

Recruiting at 33 trial locations
RT
CO
Overseen ByCharles Oh, MD
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial tests Azstarys®, a medication taken by mouth, in children aged 4 to 12 with ADHD. Azstarys® combines two substances to help improve focus and reduce hyperactivity. The study aims to see how well it works. Azstarys® combines serdexmethylphenidate and dexmethylphenidate, which are used to treat ADHD by improving focus and reducing hyperactivity.

Will I have to stop taking my current medications?

Yes, participants must stop taking their current stimulant ADHD medications 5 days before the treatment period and non-stimulant ADHD medications 14 days before. They must not take these medications until the end of the study.

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. The drug has a rapid onset and long-lasting effect, and it is safe with side effects similar to other ADHD medications.12345

Is Azstarys® (SDX/d-MPH) safe for children with ADHD?

Azstarys® (SDX/d-MPH) has been found to be generally safe for children with ADHD, with common side effects including decreased appetite and insomnia. In a 12-month study, it was well tolerated, with no unexpected safety issues, and effects on growth were minimal.12567

How is the drug Azstarys® unique for treating ADHD?

Azstarys® is unique for treating ADHD because it combines serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH) in a single capsule, offering a rapid onset and extended duration of effect, which can improve symptoms throughout the day with once-daily dosing.12589

Research Team

AC

Ann Childress, MD

Principal Investigator

Center for Psychiatry And Behavioral Medicine Inc.

Eligibility Criteria

Children aged 4-12 with ADHD who are generally healthy and not on current ADHD medication can join this study. They must meet specific criteria for ADHD diagnosis, have certain scores on ADHD scales, and be within a healthy weight range. Girls of childbearing age must agree to use birth control.

Inclusion Criteria

I can stop taking my ADHD medications as required before and during the trial.
Subjects must be in general good health as determined by the Investigator based on various assessments at Screening.
You have had symptoms of ADHD for at least 6 months before the screening visit.
See 11 more

Exclusion Criteria

I am allergic or sensitive to MPH or ingredients in the study drug.
I plan to start psychotherapy during the study.
I am not pregnant or breastfeeding, and if I can have children, I have a negative pregnancy test.
See 20 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks
1 visit (in-person)

Treatment

Participants receive Azstarys® or placebo with dose optimization over a 4-week period

4 weeks
5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Placebo
  • Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)
Trial OverviewThe trial is testing Azstarys®, which combines two drugs (SDX and d-MPH), against a placebo in children with ADHD. It's double-blind, meaning neither the participants nor the researchers know who gets the real drug or placebo until after the results are collected.
Participant Groups
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort 2: SDX/d-MPH in 6-12 year oldExperimental Treatment1 Intervention
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
Group II: Cohort 1: SDX/d-MPH in 4-5 year oldExperimental Treatment1 Intervention
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
Group III: Cohort 1: Placebo in 4-5 year oldPlacebo Group1 Intervention
matching placebo
Group IV: Cohort 2: Placebo in 6-12 year oldPlacebo Group1 Intervention
matching placebo

Find a Clinic Near You

Who Is Running the Clinical Trial?

Corium, Inc.

Lead Sponsor

Trials
9
Recruited
1,000+

Almac

Industry Sponsor

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+

Almac

Collaborator

Trials
4
Recruited
490+

Findings from Research

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.
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]
Dexmethylphenidate extended release (d-MPH-ER) significantly improved ADHD symptoms in children and adolescents compared to placebo, with 67.3% of patients showing substantial improvement on the Clinical Global Impressions scale.
While d-MPH-ER was effective, it was associated with a higher rate of reported adverse events (49.1% vs. 25.5% for placebo), indicating the need for careful monitoring of side effects during treatment.
Efficacy and safety of dexmethylphenidate extended-release capsules in children with attention-deficit/hyperactivity disorder.Greenhill, LL., Muniz, R., Ball, RR., et al.[2015]
In a study involving 54 children aged 6-12, extended-release dexmethylphenidate (d-MPH-ER) significantly improved ADHD symptoms compared to placebo, showing effectiveness as early as 1 hour postdose and maintaining superiority for up to 12 hours.
D-MPH-ER was well tolerated with no severe adverse events reported, indicating it is a safe option for improving attention and performance in children with ADHD.
Efficacy and duration of effect of extended-release dexmethylphenidate versus placebo in schoolchildren with attention-deficit/hyperactivity disorder.Silva, RR., Muniz, R., Pestreich, L., et al.[2015]

References

A Randomized, Controlled Laboratory Classroom Study of Serdexmethylphenidate and d-Methylphenidate Capsules in Children with Attention-Deficit/Hyperactivity Disorder. [2021]
Efficacy and safety of dexmethylphenidate extended-release capsules in children with attention-deficit/hyperactivity disorder. [2015]
Efficacy and duration of effect of extended-release dexmethylphenidate versus placebo in schoolchildren with attention-deficit/hyperactivity disorder. [2015]
A double-blind, placebo-controlled study of modified-release methylphenidate in children with attention-deficit/hyperactivity disorder. [2022]
Safety and Tolerability of Serdexmethylphenidate/Dexmethylphenidate Capsules in Children with Attention-Deficit/Hyperactivity Disorder: A 12-Month, Open-Label Safety Study. [2023]
Analysis of Growth Velocity in Children with Attention-Deficit/Hyperactivity Disorder Treated for up to 12 Months with Serdexmethylphenidate/Dexmethylphenidate. [2023]
Oral, intranasal, and intravenous abuse potential of serdexmethylphenidate, a novel prodrug of d-methylphenidate. [2022]
Potential Negative Effects of Dextromethorphan as an Add-On Therapy to Methylphenidate in Children With ADHD. [2020]
Comparative efficacy, acceptability, and tolerability of dexmethylphenidate versus placebo in child and adolescent ADHD: a meta-analysis of randomized controlled trials. [2020]