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Central Nervous System Stimulant
Azstarys® for ADHD (KP415P02 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
Subjects must have a body weight within the 5th and 95th percentile according to the gender-specific weight-for-age percentile charts from the Centers for Disease Control and Prevention (CDC)
New Subjects must be at least 4 years old and less than 5 years and 10 months old at Screening.
Must not have
Subject has a history of, or currently has a malignancy.
Subject has evidence of any chronic disease of the central nervous system (CNS) such as tumors, inflammation, seizure disorder, vascular disorder, potential CNS related disorders that might occur in childhood (e.g., Duchenne Muscular dystrophy, myasthenia gravis, or other neurologic or serious neuromuscular disorders), or history of persistent neurological symptoms attributable to serious head injury.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Summary
This trial evaluates the safety and efficacy of a drug to treat ADHD in 4-5 year-old children over 12 months. 100 children will take part at 20 sites.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects of Azstarys® may include decreased appetite, trouble sleeping, stomach pain, nausea, vomiting, increased heart rate, anxiety/nervousness. Since it's an open-label study where everyone gets the treatment being tested without a placebo group for comparison.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My weight is within the normal range for my age and gender according to CDC charts.
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I am between 4 years and 5 years 9 months old.
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My weight is within the normal range for my age and gender according to CDC charts.
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My blood pressure is below the high range for my age and gender.
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My caregiver and I can communicate in English or Spanish with the study team.
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I can stop taking my ADHD medications as required before and during the trial.
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My ADHD symptoms are in the top 10% for my age and sex.
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I am between 4 years and 5 years 9 months old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have or had cancer before.
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I have a chronic disease affecting my brain or nerves.
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My thyroid disorder is not under control, as shown by my TSH levels.
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I have tried methylphenidate medications without success or could not tolerate them.
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I do not have any major health issues that could affect how a study drug works in my body.
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I am allergic to methylphenidate or ingredients in the study drug.
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I have not taken seizure medications in the last 2 years.
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I have been diagnosed with a mental health or cognitive disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
A determination of safety and tolerability of up to 12 months of treatment with Azstarys
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
Trial Design
1Treatment groups
Experimental Treatment
Group I: Open LabelExperimental Treatment1 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
Find a Location
Who is running the clinical trial?
AlmacIndustry Sponsor
3 Previous Clinical Trials
396 Total Patients Enrolled
1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
246 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Worldwide Clinical TrialsOTHER
61 Previous Clinical Trials
14,207 Total Patients Enrolled
Corium, Inc.Lead Sponsor
8 Previous Clinical Trials
875 Total Patients Enrolled
1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
246 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I plan to start or continue psychotherapy during the study.I have or had cancer before.You are currently experiencing physical, sexual, or emotional abuse.You must be diagnosed with ADHD by a doctor using specific criteria and confirmed by a special interview for children and adolescents.I am between 4 years and 5 years 9 months old.I am in good health with no significant medical issues found in recent tests.I have used multiple ADHD medications recently, but I'm stable on one.You have had symptoms of ADHD for at least 6 months before the screening visit.My weight is within the normal range for my age and gender according to CDC charts.My blood pressure is below the high range for my age and gender.You must be rated as moderately ill on a scale called the Clinical Global Impressions-Severity (CGI-S) scale by a doctor.My caregiver and I can communicate in English or Spanish with the study team.I have a chronic disease affecting my brain or nerves.My thyroid disorder is not under control, as shown by my TSH levels.I can stop taking my ADHD medications as required before and during the trial.I have tried methylphenidate medications without success or could not tolerate them.My intellectual functioning is appropriate for my age.I have been treated for anxiety or panic disorder in the last year.I do not have any major health issues that could affect how a study drug works in my body.I am allergic to methylphenidate or ingredients in the study drug.I have not taken seizure medications in the last 2 years.My ADHD symptoms are in the top 10% for my age and sex.I have a psychiatric condition diagnosed in the last month, not including specific phobias or learning disorders.I do not plan to move or travel in a way that would interfere with the study schedule.I have been diagnosed with a mental health or cognitive disorder.You must have shown signs of ADHD for at least 6 months before the Screening Visit.You have a high level of protein in your urine during the screening test.You must have been diagnosed with ADHD by a doctor using specific criteria and confirmed by a special interview for children and teenagers.I do not use recreational drugs, or if I do, it's only my prescribed ADHD medication.I am between 4 years and 5 years 9 months old.
Research Study Groups:
This trial has the following groups:- Group 1: Open Label
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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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