A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 4 Study to Evaluate the Efficacy and Safety of Qudexy(R) XR in the Prevention of Migraine in Children 6 to 11 Years of Age
Upsher-Smith Laboratories
Summary
A Phase 4 study to evaluate Qudexy XR for the prevention of migraine in children 6 to 11 years of age.
Eligibility
- Age range
- 6–11 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Subject is a female or male 6 to 11 years of age, inclusive, at Visit 1 (Screening) 2. 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 3. 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 \[ICHD 3\]). 4. Subject had ≥8 self-reported headache days in the 28 days prior to Screening. 5. Subject has a PedMIDAS score \>10, indicating at least mild disruption in daily act…
Interventions
- DrugQudexy XR
Extended-Release Capsule
- DrugPlacebo
Qudexy XR Matching capsules
Locations (15)
- Upsher-Smith Clinical Trial Site #5Birmingham, Alabama
- Upsher-Smith Clinical Trial Site #15La Jolla, California
- Upsher-Smith Clinical Trials Site #3Aurora, Colorado
- Upsher-Smith Clinical Trial Site #1Stamford, Connecticut
- Upsher-Smith Clinical Trial Site #12Loxahatchee Groves, Florida
- Upsher-Smith Clinical Trial Site #8Orlando, Florida