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Stimulant
Azstarys® for ADHD (KP415P01 Trial)
Phase 4
Waitlist Available
Led By Ann Childress, MD
Research Sponsored by Corium, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject must be able and willing to wash out current stimulant ADHD medications, including herbal medications, from 5 days prior to the start of the Treatment Period, and abstain from taking these to the end of Visit 6 or ET; and wash out non-stimulant ADHD medications from 14 days prior to the start of the Treatment Period, and abstain from taking these to the end of Visit 6.
Subject must have a systolic and diastolic blood pressure below the 95th percentile for age and gender according to the 2017 AAP guidelines.
Must not have
Subject has a history of allergic reaction or a known or suspected sensitivity to MPH or any substance that is contained in the study drug.
If female, must not be pregnant or breastfeeding, and if of childbearing potential, must have a negative urine pregnancy test at the start of the Screening Period.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
Summary
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.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects may include trouble sleeping, decreased appetite, stomach pain, nausea, anxiety, irritability, mood swings and increased heart rate. These are common side effects associated with stimulant medications used for treating ADHD.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can stop taking my ADHD medications as required before and during the trial.
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My blood pressure is below the high range for my age and gender.
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I, and if applicable, my guardian or caregiver, can communicate in English or Spanish.
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I am either 4-5 years and 9 months old or 6-12 years and 9 months old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am allergic or sensitive to MPH or ingredients in the study drug.
Select...
I am not pregnant or breastfeeding, and if I can have children, I have a negative pregnancy test.
Select...
I have a long-term brain condition or had serious head injury symptoms.
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I have used ADHD medications from different classes in the last 30 days.
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My thyroid disorder is not under control, as shown by my TSH levels.
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My urine test for MPH was positive.
Select...
I do not have any psychiatric conditions that could affect my participation in the study.
Select...
I have or had cancer before.
Select...
I did not respond well or could not tolerate treatment with MPH medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
A comparison of the change in mean ADHD Rating Scale (ADHD-RS) results from baseline to end of treatment between active and placebo treatments.
Secondary study objectives
A comparison of the change in mean Clinical Global Impressions-Improvement (CGI-I) results from Visit 3 to end of treatment between active and placebo treatments.
A comparison of the change in mean Clinical Global Impressions-Severity (CGI-S) results from baseline to end of treatment between active and placebo treatments.
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)
2023
Completed Phase 4
~250
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Central nervous system stimulants, such as Dexmethylphenidate and Serdexmethylphenidate (components of Azstarys®), work primarily by increasing the levels of neurotransmitters dopamine and norepinephrine in the brain. These neurotransmitters play key roles in attention and behavior regulation.
By enhancing their activity, these medications help improve focus, reduce impulsivity, and control hyperactive behaviors in ADHD patients. This mechanism is crucial as it directly addresses the core symptoms of ADHD, thereby improving daily functioning and quality of life for those affected.
Comparative efficacy and tolerability of medications for attention-deficit hyperactivity disorder in children, adolescents, and adults: a systematic review and network meta-analysis.Comparing the efficacy of medications for ADHD using meta-analysis.
Comparative efficacy and tolerability of medications for attention-deficit hyperactivity disorder in children, adolescents, and adults: a systematic review and network meta-analysis.Comparing the efficacy of medications for ADHD using meta-analysis.
Find a Location
Who is running the clinical trial?
AlmacIndustry Sponsor
3 Previous Clinical Trials
246 Total Patients Enrolled
1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
123 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Corium, Inc.Lead Sponsor
8 Previous Clinical Trials
751 Total Patients Enrolled
1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
123 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Premier Research Group plcIndustry Sponsor
63 Previous Clinical Trials
73,608 Total Patients Enrolled
3 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
356 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic or sensitive to MPH or ingredients in the study drug.I plan to start psychotherapy during the study.I can stop taking my ADHD medications as required before and during the trial.You have had symptoms of ADHD for at least 6 months before the screening visit.I am not pregnant or breastfeeding, and if I can have children, I have a negative pregnancy test.You must have certain scores on the doctor's assessment scale and the ADHD symptom rating scale from the past 6 months.I have a long-term brain condition or had serious head injury symptoms.I have used ADHD medications from different classes in the last 30 days.You must meet specific criteria for a diagnosis of ADHD based on clinical evaluation and a special interview for children and teenagers.My thyroid disorder is not under control, as shown by my TSH levels.My urine test for MPH was positive.You have a high level of protein in your urine.I am not on any medications or have conditions that would exclude me from the study.I do not have any psychiatric conditions that could affect my participation in the study.I do not plan to move or travel in a way that would interfere with the study schedule.You have had serious allergic reactions to multiple types of medications.My blood pressure is below the high range for my age and gender.You are currently experiencing physical, sexual, or emotional abuse.My intellectual functioning is appropriate for my age, as confirmed by a doctor.I, and if applicable, my guardian or caregiver, can communicate in English or Spanish.I am either 4-5 years and 9 months old or 6-12 years and 9 months old.My weight is within the normal range for my age and gender according to CDC charts.I have or had cancer before.I did not respond well or could not tolerate treatment with MPH medications.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1: Placebo in 4-5 year old
- Group 2: Cohort 1: SDX/d-MPH in 4-5 year old
- Group 3: Cohort 2: SDX/d-MPH in 6-12 year old
- Group 4: Cohort 2: Placebo in 6-12 year old
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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