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Stimulant
Azstarys® for ADHD (KP415P01 Trial)
Phase 4
Recruiting
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 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.
KP415P01 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
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 • NCT0042927336%
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
69,129 Total Patients Enrolled
3 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
329 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.
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?
Met criteria
Did not meet 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
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