Qudexy XR for Pediatric Migraine Prevention
What You Need to Know Before You Apply
What is the purpose of this trial?
A Phase 4 study to evaluate Qudexy XR for the prevention of migraine in children 6 to 11 years of age.
Will I have to stop taking my current medications?
The trial requires that participants do not change their migraine prevention medication during the study. If you are currently taking such medication and have changed the dose within 28 days before the study, you may not be eligible.
Is Qudexy XR (topiramate) safe for children?
How is Qudexy XR different from other drugs for pediatric migraine prevention?
Qudexy XR is unique because it is an extended-release form of topiramate, which allows for once-daily dosing, potentially improving convenience and adherence compared to other treatments that may require multiple doses per day. While topiramate is commonly used for adult migraines, its use in children is less common, making Qudexy XR a novel option for pediatric migraine prevention.14678
What data supports the effectiveness of the drug Qudexy XR for preventing migraines in children?
Are You a Good Fit for This Trial?
This trial is for children aged 6 to 11 who weigh between 17.0 kg and less than 50.0 kg, have had migraines for at least six months, and experience more than eight headache days per month. They should not have failed topiramate treatment before or be on certain contraceptives or migraine prevention medications.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Qudexy XR or placebo for the prevention of migraine
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Qudexy XR
Qudexy XR is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Upsher-Smith Laboratories
Lead Sponsor