A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder
This research study is investigating a new treatment for irritability in children and teenagers with autism. The treatment involves a combination of two medications, KarXT and KarX-EC. Irritability can be a challenging symptom for individuals with autism, affecting their daily lives and well-being. This study aims to find out if this specific combination of medications is safe and effective in reducing these irritable feelings. Participants will be given either the new medication combination or a placebo (a dummy pill with no active medicine) to compare their effects. This is a Phase 3 study, meaning it's one of the final steps before a medicine might be approved for wider use.
במבט חטוף
על מה המחקר הזה?
This research is looking into a new way to help children and teenagers aged 5 to 17 who have autism and experience significant irritability. Irritability can mean things like having frequent tantrums, getting very upset, or being easily frustrated. These feelings can be difficult for young people and their families, impacting their daily lives at home and school. The study wants to see if a combination of two medications, called KarXT and KarX-EC, can help manage these symptoms.
The medications being tested are designed to work on certain brain pathways that might be involved in irritability. By taking part in the study, participants will help doctors understand more about how these medications work and if they are a safe and effective option. This is important because finding better ways to manage irritability can improve the quality of life for young people with autism.
This is a 'Phase 3' study, which means it’s one of the final stages of testing a new medicine. Before a new medicine can be used more widely, it needs to be carefully studied in many people to make sure it's safe and that it works as intended. Your participation could contribute to new treatment options for many other children and teenagers with autism in the future.
נקודות עיקריות
- This study evaluates a new medication (KarXT + KarX-EC) for irritability in children and teens with autism.
- It aims to find out if the new treatment is safe and effective.
- Participants will receive either the new medication or a placebo.
- The study involves regular visits and health checks.
- Participation could help develop new treatments for autism-related irritability.
- אתה יכול להפסיק להשתתף בכל עת.
מי עשוי להיות זכאי?
To join this study, children and teenagers must be between 5 and 17 years old and have an official diagnosis of autism. They also need to be experiencing noticeable irritability, which medical staff will measure using specific questionnaires and ratings.
There are also some reasons why someone might not be able to join. For example, if they have other serious mental health conditions like bipolar disorder or schizophrenia, they wouldn't be eligible. However, if a child also has ADHD (attention deficit/hyperactivity disorder) and it's well-managed and stable, they might still be able to take part.
It's also important that participants don't have any major medical illnesses that could put them at risk, or problems with their blood test results. The doctors will check for any risk of suicidal thoughts. There might be some other specific rules depending on the study, which the medical team will explain.
האם מחקר זה יכול להתאים לך?
ענה על השאלות המהירות הללו כדי לבדוק אם אתה עשוי להיות זכאי. זהו מדריך בלבד — צוות המחקר מקבל את ההחלטה הסופית.
- Is your child aged between 5 and 17 years old?
- Does your child have an official diagnosis of autism?
- Does your child experience significant irritability?
- Does your child *not* have other major mental health conditions like bipolar disorder or schizophrenia?
- Is your child's overall health stable?
- Are there no immediate concerns about your child's safety or suicidal thoughts?
מה כרוך בהשתתפות?
If you decide to take part, your child will be given either the new medication combination (KarXT + KarX-EC) or a placebo (a dummy pill with no medicine). You won't know which one they are receiving. Your child will have regular visits to the clinic where doctors and nurses will do assessments to see how they are feeling and if the medication is helping with irritability. These assessments will involve discussions and questionnaires. They will also have physical checks and blood tests to make sure they are safe. Throughout the study, your child will be carefully monitored. The total duration of participation, including all follow-up appointments, will be clearly explained by the study team.
סיכונים ותועלות פוטנציאליים
Locations (55)
- Local Institution - 0062מיקוד מאומתפניקס, ארצות הברית
- מוסד מקומי - 0001מיקוד מאומתBentonville, United States
- Local Institution - 0013מיקוד מאומתגלנדייל, ארצות הברית
- Local Institution - 0117מיקוד מאומתלוס אנג'לס, ארצות הברית
- Local Institution - 0126מיקוד מאומתאורנג', ארצות הברית
- Local Institution - 0115מיקוד מאומתSan Juan Capistrano, United States
- Local Institution - 0116מיקוד מאומתSan Rafael, United States
- Local Institution - 0080מיקוד מאומתאורלנדו, ארצות הברית
- Local Institution - 0014מיקוד מאומתשיקגו, ארצות הברית
- Local Institution - 0006מיקוד מאומתלקסינגטון, ארצות הברית
- Local Institution - 0051מיקוד מאומתלקסינגטון, ארצות הברית
- Local Institution - 0016מיקוד מאומתColumbia, United States
שאלות נפוצות
What is KarXT + KarX-EC?
It's a combination of two new medications being tested to see if they can help reduce irritability in young people with autism.
מהו 'פלצבו'?
A placebo is a dummy pill that looks like the study medication but contains no active ingredients. It's used to compare against the real medicine.
Will we know if my child is getting the real medicine or the placebo?
No, neither you nor the study team will know during the study. This helps ensure fair results.
What happens if we want to stop participating?
You can withdraw your child from the study at any time, for any reason, and it won't affect their usual medical care.
כמה זמן יימשך המחקר?
The study team will tell you the exact duration of your child's participation, including all visits and follow-up.
כיצד לגלות עוד
מרכז קשר לניסויים קליניים של BMS www.BMSClinicalTrials.com
תמיד התייעץ עם רופא המשפחה או המומחה שלך לפני שתחליט להשתתף במחקר.
מעוניינים להשתתף?
דיון
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