Azstarys® for ADHD

(KP415P01 Trial)

No longer recruiting at 33 trial locations

Overseen By Charles Oh, MD

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Corium, Inc.

Must not be taking: Anticonvulsants, Antidepressants

Disqualifiers: Bipolar, Major depression, Autism, others

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

Compensation: Varies

Number of Visits: 6

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Azstarys® for children with ADHD (attention-deficit/hyperactivity disorder). The goal is to determine how well Azstarys® manages ADHD symptoms compared to a placebo (a pill with no active drug). The trial divides participants into two groups: children aged 4 to 5 and those aged 6 to 12. It may suit children who have struggled with ADHD symptoms for at least six months and are not currently taking other ADHD medications. As a Phase 4 trial, Azstarys® has already received FDA approval and proven effective, and this research aims to understand its benefits for more patients.

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 is the safety track record for Azstarys®?

Research has shown that Azstarys®, a combination of serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH), is generally safe for children with ADHD. A year-long study found this treatment to be safe and well-tolerated, similar to other medications. No unexpected safety issues emerged.

Additionally, an FDA safety review found no increased risk of serious heart problems in children using ADHD medications like Azstarys®. This indicates that the treatment is as safe as other available ADHD medications.

Overall, evidence suggests that Azstarys® is a well-tolerated option for managing ADHD symptoms in children. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Azstarys® for ADHD because it combines serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH) in a unique formulation. Unlike traditional ADHD medications, which often rely solely on immediate-release or extended-release forms of methylphenidate, Azstarys® integrates a prodrug, SDX, with d-MPH to potentially provide a smoother onset and longer duration of symptom control. This combination could offer more consistent symptom management throughout the day, reducing the peaks and troughs commonly experienced with other treatments. Additionally, the varied dosing options allow for tailored treatment based on the specific needs and age of the patient, which is a significant advantage over many current ADHD medications.

What is the effectiveness track record for Azstarys® in treating ADHD in children?

Research has shown that Azstarys®, a combination of serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH), effectively treats ADHD. In this trial, some participants will receive SDX/d-MPH, while others will receive a placebo. Studies have found that Azstarys® can significantly improve symptoms, as reflected in scores from the Attention-Deficit/Hyperactivity Disorder Rating Scale. Over 30% of patients have demonstrated major improvement, with some experiencing a reduction in symptoms by 50% or more. Additionally, a 12-month study confirmed that Azstarys® is safe and generally well-tolerated, similar to other ADHD medications. While some slowing in growth may occur, these effects are not considered medically significant. ^{1 6 7 8 9}

Who Is on the Research Team?

Ann Childress, MD

Principal Investigator

Center for Psychiatry And Behavioral Medicine Inc.

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The 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.

How Is the Trial Designed?

Group I: Cohort 2: SDX/d-MPH in 6-12 year old Experimental Treatment 1 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 old Experimental Treatment 1 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 old Placebo Group 1 Intervention

matching placebo

Group IV: Cohort 2: Placebo in 6-12 year old Placebo Group 1 Intervention

matching placebo

Who Is Running the Clinical Trial?

Corium, Inc.

Lead Sponsor

Trials

9

Recruited

1,000+

Almac

Industry Sponsor

Trials

4

Recruited

490+

Prometrika, LLC

Industry Sponsor

Premier Research

Collaborator

Premier Research Group plc

Collaborator

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of dexmethylphenidate extended-release capsules in children with attention-deficit/hyperactivity disorder. Greenhill, LL., Muniz, R., Ball, RR., et al.[2015]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36809150/

A 12-Month, Open-Label Safety Study In this 1-year study, SDX/d-MPH was found to be safe and well tolerated and comparable with other methylphenidate products, with no unexpected safety findings.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37204277/

Analysis of Growth Velocity in Children with Attention ... In this post hoc analysis of the 12-month study, the objective was to characterize the effect of SDX/d-MPH on growth in children with ADHD over 12 months.

3. tandfonline.com tandfonline.com/doi/full/10.1080/14796708.2024.2422233

Serdexmethylphenidate/dexmethylphenidate (SDX/d-MPH) ... The results showed some slowing in weight and height gain during the one-year period, but the effects were in a range not considered to be clinically ...

4. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1310483/pdf

Serdexmethylphenidate/ dexmethylphenidate for children ... Responder rate of ≥30% (A) and ≥50% (B) as assessed with the Attention-Deficit/Hyperactivity Disorder Rating Scale-5 (intent-to-treat population) ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06000501

Duration and Efficacy of Azstarys on Adult ADHD ... This is a single-site study. One purpose of this trial is to extend the safety and efficacy evidence basis for Azstarys in adults with ADHD.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10031142/

Safety and Tolerability of Serdexmethylphenidate ... In this 1-year study, SDX/d-MPH was found to be safe and well tolerated and comparable with other methylphenidate products, with no unexpected safety findings.

7. azstarys-pro.com azstarys-pro.com/safety

ADHD Patient Safety Profiles | AZSTARYS® HCP Learn about the safety of AZSTARYS® (serdexmethylphenidate and dexmethylphenidate) in ADHD patients aged 6 years and older. See full safety information.

8. mayoclinic.org mayoclinic.org/drugs-supplements/serdexmethylphenidate-and-dexmethylphenidate-oral-route/description/drg-20510796

Serdexmethylphenidate and dexmethylphenidate (oral route) Serdexmethylphenidate and dexmethylphenidate combination is used to treat attention deficit hyperactivity disorder (ADHD).

9. fda.gov fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-safety-review-update-medications-used-treat-attention

Safety Review Update of Medications used to treat ADHD Study findings reported no evidence of increased risk of serious cardiovascular effects among children and young people who use ADHD medications.