Azstarys® for ADHD

(KP415P02 Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on testing the safety and tolerability of Azstarys® (a combination of serdexmethylphenidate and dexmethylphenidate) in young children with ADHD, a condition affecting attention and behavior control. Researchers will observe how children aged 4 to 5 years respond to the medication over 12 months to ensure its safety for their use. The study seeks children who have experienced ADHD symptoms for at least six months. As a Phase 4 trial, this research aims to understand how this already FDA-approved and effective treatment benefits more patients.

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 is the safety track record for Azstarys®?

Research has shown that combining serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH) is safe and well-tolerated for treating ADHD. In a year-long study, this treatment presented no unexpected safety issues and matched the safety profile of similar medications. Another study involving children aged 6 to 12 found it effective for ADHD and easy for them to handle. Additionally, no evidence indicates a higher risk of serious heart problems in children using ADHD medications like Azstarys®. This suggests the treatment is generally safe, especially since it is already approved for older 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 way that's different from current treatments. Most ADHD medications, like standard methylphenidate or amphetamines, focus on immediate release or extended-release formulations. Azstarys® stands out with its unique pairing of SDX and d-MPH, which aims to provide a smoother effect throughout the day with potentially fewer peaks and troughs in symptom control. This combination could offer improved symptom management with a reduced risk of side effects, making it an intriguing option for individuals with ADHD.

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

Research shows that Azstarys®, a combination of serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH), reduces ADHD symptoms. Studies with children aged 6-12 demonstrated significant improvement in ADHD symptoms compared to a placebo. A 1-year safety study found that SDX/d-MPH was well tolerated, similar to other methylphenidate products, with no unexpected safety issues. Although some slowing in growth was observed, it remained within a range not considered clinically significant. Overall, Azstarys® has proven effective and safe for managing ADHD symptoms in older children, supporting its potential use in younger age groups. ^{1 6 7 8 9}

Who Is on the Research Team?

Ann Childress, M.D.

Principal Investigator

Center for Psychiatry And Behavioral Medicine Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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+

Published Research Related to This Trial

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]

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]

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]

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. 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) ...

3. 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.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34714120/

A Randomized, Controlled Laboratory Classroom Study of ... Conclusions: SDX/d-MPH showed significant improvement in ADHD symptoms compared with placebo in children 6-12 years of age, with a rapid onset ...

5. 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 ...

6. liebertpub.com liebertpub.com/doi/10.1089/cap.2022.0076

Safety and Tolerability of Serdexmethylphenidate ... A pivotal double-blind (DB) study of children aged 6–12 years with ADHD demonstrated efficacy for ADHD with good tolerability.

7. 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).

8. 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.

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.