Qudexy XR for the Prevention of Migraine in Children 6 to 11 Years Old
NCT ID: NCT04748601
Last Updated: 2025-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
132 participants
INTERVENTIONAL
2021-02-19
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Qudexy XR Matching capsules
Qudexy XR
Qudexy XR
Extended-Release Capsule
Interventions
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Qudexy XR
Extended-Release Capsule
Placebo
Qudexy XR Matching capsules
Eligibility Criteria
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Inclusion Criteria
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 activities, and \<140, indicating extreme disability that may require more comprehensive, multi component therapy.
Exclusion Criteria
2. Subject is currently receiving treatment or has used Botulinum toxin (Botox®) within 3 months prior to Visit 1 (Screening).
3. 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.
4. 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.
5. Subject has previously failed an adequate trial of \>3 migraine preventative medications.
6. Subject has a known history of allergic reaction to topiramate or any excipient in Qudexy XR.
7. Subject has a diagnosis or history of disease that may interfere with safety or evaluation of the study drug.
8. Subject is currently using an investigational drug or device or has used such within 30 days prior to Visit 1.
9. Subject has begun menses and any of the following:
1. Subject has tested positive for pregnancy; OR
2. Subject is pregnant, planning pregnancy, or lactating; OR
3. 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.
6 Years
11 Years
ALL
No
Sponsors
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Upsher-Smith Laboratories
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Other Identifiers
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P255-501
Identifier Type: -
Identifier Source: org_study_id
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