Status and phase
Conditions
Treatments
About
A Phase 4 study to evaluate Qudexy XR for the prevention of migraine in children 6 to 11 years of age.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Subject has continuous migraines, defined as an unrelenting headache for a 28-day period.
Subject is currently receiving treatment or has used Botulinum toxin (Botox®) within 3 months prior to Visit 1 (Screening).
Subject is currently receiving migraine prevention medication and has initiated or changed the dose within 28 days of Screening or is unwilling to avoid making a change during the duration of the study.
Subject has previously failed an adequate trial of topiramate (at least 3 months duration at a clinically appropriate dose) for prophylaxis of migraine headache due to lack of efficacy or AEs.
Subject has previously failed an adequate trial of >3 migraine preventative medications.
Subject has a known history of allergic reaction to topiramate or any excipient in Qudexy XR.
Subject has a diagnosis or history of disease that may interfere with safety or evaluation of the study drug.
Subject is currently using an investigational drug or device or has used such within 30 days prior to Visit 1.
Subject has begun menses and any of the following:
Primary purpose
Allocation
Interventional model
Masking
132 participants in 2 patient groups, including a placebo group
Loading...
Central trial contact
PPD Laboratories
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal