Qudexy XR for the Prevention of Migraine in Children 6 to 11 Years Old
ConditionMigraine Disorders
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age6-11
SponsorUpsher-Smith Laboratories
About this trial
A Phase 4 study to evaluate Qudexy XR for the prevention of migraine in children 6 to 11 years of age.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Qudexy XR
- Placebo
Treatment groups
132 Participants
are divided into 2 treatment groupsLocations
15Alabama
Upsher-Smith Clinical Trial Site #535205, Birmingham United States
California
Upsher-Smith Clinical Trial Site #1592093, La Jolla United States
Colorado
Upsher-Smith Clinical Trials Site #380045, Aurora United States
Connecticut
Upsher-Smith Clinical Trial Site #106901, Stamford United States
Sponsors and collaborators
Upsher-Smith Laboratories
Lead sponsor
Source ClinicalTrials.gov