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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

KP415P01 Trial 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.

KP415P01 Trial 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.

KP415P01 Trial 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

KP415P01 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

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research allowing for the inclusion of participants over 50 years old?

"In order to be eligible, individuals must fall within the age bracket of 4 and 12. Additionally, this trial has a total of 111 participants under 18 years old and 35 who are over 65."

Answered by AI

Is my profile compatible with the requirements for this research endeavor?

"This clinical trial requires that interested candidates have a diagnosis of attention deficit hyperactivity disorder (ADHD), are between the ages of 4 and 12, and can commit to participation. Approximately 230 individuals need to be enrolled for this research project."

Answered by AI

Are there any vacancies available for individuals to join the experiment?

"Clinicaltrials.gov reveals that this experiment is currently in search of volunteers, with an original posting date of 2/20/2023 and a recent update on the day after."

Answered by AI

In what locations are this investigation's facilities located?

"This investigation is currently recruiting patients from 22 separate sites, which include Little Rock, Centennial and Clermont. To minimize the associated burden of travel, interested applicants should select a location nearby them to ensure their convenience."

Answered by AI

How many individuals can enroll in this experiment?

"Corium, Inc., the sponsor of this trial, requires 230 eligible participants to successfully carry out their study. Recruitment will take place at Preferred Research Partners in Little Rock and IMMUNOe International Research centre located in Centennial, Colorado."

Answered by AI

Has Cohort 1: SDX/d-MPH received government clearance for use in children aged 4-5?

"Given the Phase 4 nature of this trial, which means it has already been approved, our team assigned a 3 to Cohort 1: SDX/d-MPH in 4-5 year olds for safety."

Answered by AI

Who else is applying?

What site did they apply to?
IPS Research Company, Inc.
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I have adhd and nothing seems to help. It's hard to get my provider..ARPN to do anymore meds since she can't write for stimulants and the dr she works under is full.
PatientReceived 1 prior treatment
~114 spots leftby May 2025