Qudexy XR for the Prevention of Migraine in Children 6 to 11 Years Old
- Registration Number
- NCT04748601
- Lead Sponsor
- Upsher-Smith Laboratories
- Brief Summary
A Phase 4 study to evaluate Qudexy XR for the prevention of migraine in children 6 to 11 years of age.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 132
- 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.
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Subject has continuous migraines, defined as an unrelenting headache for a 28-day period.
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Subject is currently receiving treatment or has used Botulinum toxin (Botox®) within 3 months prior to Visit 1 (Screening).
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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.
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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.
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Subject has previously failed an adequate trial of >3 migraine preventative medications.
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Subject has a known history of allergic reaction to topiramate or any excipient in Qudexy XR.
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Subject has a diagnosis or history of disease that may interfere with safety or evaluation of the study drug.
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Subject is currently using an investigational drug or device or has used such within 30 days prior to Visit 1.
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Qudexy XR Qudexy XR -
- Primary Outcome Measures
Name Time Method Change from Baseline (last 28 days Run-In Period) in the monthly number of headache days during the 8-week Maintenance Period based on the diary. 16 Weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
Upsher-Smith Clinical Trial Site #5
🇺🇸Birmingham, Alabama, United States
Upsher-Smith Clinical Trial Site #15
🇺🇸La Jolla, California, United States
Upsher-Smith Clinical Trials Site #3
🇺🇸Aurora, Colorado, United States
Upsher-Smith Clinical Trial Site #1
🇺🇸Stamford, Connecticut, United States
Upsher-Smith Clinical Trial Site #12
🇺🇸Loxahatchee Groves, Florida, United States
Upsher-Smith Clinical Trial Site #8
🇺🇸Orlando, Florida, United States
Upsher-Smith Clinical Trial Site #14
🇺🇸Tampa, Florida, United States
Upsher-Smith Clinical Trial Site #2
🇺🇸Ann Arbor, Michigan, United States
Upsher-Smith Clinical Trial Site #11
🇺🇸Jackson, Mississippi, United States
Upsher-Smith Clinical Trial Site #10
🇺🇸Bridgeton, Missouri, United States
Upsher-Smith Clinical Trial Site #4
🇺🇸Cincinnati, Ohio, United States
Upsher-Smith Clinical Trial Site #6
🇺🇸Portland, Oregon, United States
Upsher-Smith Clinical Trials Site #7
🇺🇸Springfield, Oregon, United States
Upsher-Smith Clinical Trial Site #13
🇺🇸McAllen, Texas, United States
Upsher-Smith Clinical Trial Site #9
🇺🇸Huntington, West Virginia, United States