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Azstarys® for ADHD (KP415P02 Trial)
KP415P02 Trial 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.
KP415P02 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowKP415P02 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2011 Phase 4 trial • 212 Patients • NCT00429273KP415P02 Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Open Label
- 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.
- 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
Has Open Label been given the stamp of approval by the FDA?
"Open Label has already been approved, so it obtained the maximum safety score of 3."
Is this investigation still available to participants?
"According to the information available on clinicaltrials.gov, this medical trial is currently in search of participants. It was first advertised on May 24th 2023 and has seen its most recent update as well being posted on that same date."
Does this trial include participants of ages 45 and above?
"The trial particulars stipulate that suitable participants must be aged between 4 and 5. Additionally, there are 123 trials for minors and 38 trials specifically dedicated to elderly patients above the age of 65."
How many centers are executing this experiment?
"At present, this medical trial is enrolling patients across 21 sites. These locations span from Centennial to Clermont and Jacksonville as well as 18 other cities. To reduce the burden of travel, it would be wise for participants to select a site nearby them."
How many subjects are being enrolled in this clinical trial?
"For the completion of this trial, Corium Inc. requires 100 individuals who qualify within the predetermined criteria. Research is to be conducted at IMMUNOe International Research Center in Centennial, Colorado and Vertex Group Inc in Clermont, Florida."
What are the criteria necessary to qualify for this experiment?
"This trial requires the recruitment of one hundred 4 to 5 year-olds, diagnosed with ADHD. In order for a patient's participation eligibility to be confirmed, they must have exhibited symptoms for at least six months prior and receive an age appropriate score on the Clinical Global Impressions-Severity scale. Furthermore, their body weight should fall within the specified percentile range based on gender according to Centers For Disease Control And Prevention standards and any stimulant or non-stimulant medications currently taken need to be discontinued prior to enrolment."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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