Status:
RECRUITING
Qudexy XR for the Prevention of Migraine in Children 6 to 11 Years Old
Lead Sponsor:
Upsher-Smith Laboratories
Conditions:
Migraine Disorders
Eligibility:
All Genders
6-11 years
Phase:
PHASE4
Brief Summary
A Phase 4 study to evaluate Qudexy XR for the prevention of migraine in children 6 to 11 years of age.
Eligibility Criteria
Inclusion
- Subject is a female or male 6 to 11 years of age, inclusive, at Visit 1 (Screening)
- Subject weighs at least 17.0 kg and less than 50.0 kg at Visit 1 (Screening) based on 95 percentile weight for the age range.11
- Subject has at least a 6-month history of headaches consistent with a diagnosis of migraine with or without aura (International Classification of Headache Disorders, 3rd Edition \[ICHD 3\]).
- Subject had ≥8 self-reported headache days in the 28 days prior to Screening.
- Subject has a PedMIDAS score \>10, indicating at least mild disruption in daily activities, and \<140, indicating extreme disability that may require more comprehensive, multi component therapy.
Exclusion
- 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:
- Subject has tested positive for pregnancy; OR
- Subject is pregnant, planning pregnancy, or lactating; OR
- Subject is taking an oral hormonal contraceptive (either combined \[estrogen and progestogen containing\] or progestogen-only) and is unable or unwilling to switch to an alternative highly effective contraceptive method.
Key Trial Info
Start Date :
February 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT04748601
Start Date
February 19 2021
End Date
September 1 2026
Last Update
January 27 2025
Active Locations (15)
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1
Upsher-Smith Clinical Trial Site #5
Birmingham, Alabama, United States, 35205
2
Upsher-Smith Clinical Trial Site #15
La Jolla, California, United States, 92093
3
Upsher-Smith Clinical Trials Site #3
Aurora, Colorado, United States, 80045
4
Upsher-Smith Clinical Trial Site #1
Stamford, Connecticut, United States, 06901