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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

Summary

This trial will study the efficacy and safety of a medicine (Azstarys®) for treating ADHD in children 4-12 years old. 130 & 100 children from 20 sites will be enrolled and randomized.

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.Check my eligibility
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.See study design
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 below
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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:
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I am allergic or sensitive to MPH or ingredients in the study drug.
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I am not pregnant or breastfeeding, and if I can have children, I have a negative pregnancy test.
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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.
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I do not have any psychiatric conditions that could affect my participation in the study.
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I have or had cancer before.
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I did not respond well or could not tolerate treatment with MPH medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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.

Side effects data

From 2011 Phase 4 trial • 212 Patients • NCT00429273
36%
Decreased Appetite
34%
Insomnia
33%
Headache
26%
Irritability
23%
Abdominal Pain
23%
Sedation
23%
Lethargy
21%
Somnolence
17%
Fatigue
14%
Abdominal Pain Upper
11%
Affect Lability
10%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1: Guan-Guan+Placebo
Group 2: Placebo-Placebo+DMPH
Group 3: Guan-Guan+DMPH

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

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.

Find a Location

Who is running the clinical trial?

AlmacIndustry Sponsor
3 Previous Clinical Trials
250 Total Patients Enrolled
1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
100 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Corium, Inc.Lead Sponsor
8 Previous Clinical Trials
729 Total Patients Enrolled
1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
100 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Premier Research Group plcIndustry Sponsor
62 Previous Clinical Trials
73,596 Total Patients Enrolled
3 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
329 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Media Library

Placebo (Stimulant) Clinical Trial Eligibility Overview. Trial Name: NCT05685732 — Phase 4
Attention Deficit Hyperactivity Disorder (ADHD) Research Study Groups: Cohort 1: Placebo in 4-5 year old, Cohort 1: SDX/d-MPH in 4-5 year old, Cohort 2: SDX/d-MPH in 6-12 year old, Cohort 2: Placebo in 6-12 year old
Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05685732 — Phase 4
Placebo (Stimulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05685732 — Phase 4
~105 spots leftby Jul 2025
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