Randomized Study in Children and Adolescents With Migraine: Acute Treatment
This research study is looking into a new medication called rimegepant (also known as BHV-3000) for children and teenagers between 6 and 17 years old who suffer from migraines. The main goal is to find out if this medication is both safe and effective at treating moderate to severe migraine attacks. Participants will either receive the new medication or a 'dummy pill' (placebo) that looks the same but contains no active medicine. This allows researchers to compare the effects accurately. The study is particularly interested in how well the medication works to stop or lessen the severity of a migraine once it has started.
At a glance
What is this study about?
This clinical trial is designed to investigate a new medication, rimegepant (or BHV-3000), as a treatment for acute migraine attacks in children and adolescents aged 6 to 17. Migraine can be very disruptive, especially for young people, and finding effective treatments is really important. This study is in 'Phase 3', which means the medication has already shown some promise in earlier tests, and now researchers need to gather more detailed information about its safety and effectiveness in a larger group of patients.
The study aims to compare rimegepant directly with a 'placebo', which is a pill that looks identical but doesn't contain any active drug. This comparison helps researchers understand if any improvements experienced by participants are genuinely due to the new medication or if they happen naturally, for example, because of the care they receive during the study. It's a standard and crucial way to test new medicines.
Ultimately, the findings from this study could help determine if rimegepant could become a new treatment option for young people in the UK experiencing moderate to severe migraine attacks. It's about finding better ways to manage this common and often debilitating condition in children and teenagers, helping them get back to their everyday lives more quickly.
Key takeaways
- This study is testing a new migraine medication for young people.
- It's for children and teenagers aged 6-17 with moderate to severe migraines.
- Participants will receive either the new drug or a dummy pill.
- The goal is to see if the medication is safe and effective.
- Your regular migraine prevention medicines might be allowed.
- You can stop participating at any point.
Who may be eligible?
This study is looking for children and teenagers between 6 and 17 years old who have been diagnosed with migraine for at least six months. To join, you should typically experience between 1 and 8 moderate to severe migraine attacks each month, with each attack lasting more than three hours if left untreated. You also need to be able to tell the difference between a migraine and other types of headaches.
There are some conditions that would prevent someone from joining. For example, if you have other types of headaches like cluster headaches or a rare type called hemiplegic migraine. You also wouldn't be able to participate if you have certain serious mental health conditions or have a history of drug or alcohol misuse.
If you're currently taking medication to prevent migraines, that's often allowed, as long as the dose has been stable for at least 12 weeks. However, you cannot be taking certain types of migraine preventative medications called CGRP antagonists, whether they are injections or pills. You'll also need to weigh more than 40 kilograms (about 6 stone 4 pounds) and be able to provide blood samples during the study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 6 and 17 years old?
- Have you been diagnosed with migraine for at least 6 months?
- Do you typically have 1-8 moderate/severe migraines per month?
- Are you able to tell the difference between a migraine and other headaches?
- Do you weigh more than 40 kilograms (about 6 stone 4 pounds)?
- Are you NOT currently using CGRP antagonist medications for migraine prevention?
What does participation involve?
If you decide to take part in this study, you would first have a screening visit to check if you meet all the requirements. This might include reviewing your medical history, some assessments, and possibly blood tests. If you qualify, you would then receive either the study medication (rimegepant) or a placebo (a dummy pill) to take when you have a moderate or severe migraine attack.
The study would involve regular contact, which could be in-person visits, phone calls, or online questionnaires, to track how you're feeling, record your migraine attacks, and notice any side effects. You might need to provide blood samples at different points. The total duration of your participation would depend on the study's plan, but all details would be explained clearly before you agree to join. You are always free to ask questions and can withdraw from the study at any time without giving a reason.
Potential risks and benefits
Locations (248)
- Achieve Clinical Research, LLC d/b/a Accel Research Sites-Neurology and Neurodiagnostic of AlabamaVerified postcodeBirmingham, United States· Active not recruiting
- Perseverance Research Center, LLCVerified postcodeScottsdale, United States· Recruiting
- Physicians Research GroupVerified postcodeTempe, United States· Active not recruiting
- Advanced Research Center, Inc.Verified postcodeAnaheim, United States· Recruiting
- Adult & Child Neurology Medical AssociatesVerified postcodeCosta Mesa, United States· Recruiting
- ProScience Research GroupVerified postcodeCulver City, United States· Active not recruiting
- Memorial Health ServicesVerified postcodeFountain Valley, United States· Recruiting
- Neuro-Pain Research CenterVerified postcodeFresno, United States· Recruiting
- Regents of the University of California (UC San Diego)Verified postcodeLa Jolla, United States· Recruiting
- Adult & Child Neurology Medical AssociatesVerified postcodeLong Beach, United States· Recruiting
- Miller Children's & Women's Hospital Long BeachVerified postcodeLong Beach, United States· Recruiting
- National Research InstituteVerified postcodeLos Angeles, United States· Active not recruiting
Common questions
What is rimegepant?
Rimegepant is a new medication being tested to treat migraine attacks once they start, to help reduce pain and other symptoms.
What does 'Phase 3' mean for a study?
Phase 3 means the medication has successfully passed earlier safety tests, and now researchers are testing it on a larger group of people to confirm its effectiveness and gather more information about safety.
Will I definitely get the new medication?
No, participants are randomly assigned to receive either the new medication or a 'placebo' (a dummy pill) to allow for a fair comparison.
Can I continue my usual migraine prevention medication?
In many cases, yes, as long as the dose has been stable for at least 12 weeks. However, certain types of preventative medications (CGRP antagonists) are not allowed.
What if I want to stop participating?
You can withdraw from the study at any time, for any reason, without needing to explain why, and it will not affect your standard medical care.
How to find out more
Pfizer Pfizer CT.gov Call Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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