Qudexy XR for the Prevention of Migraine in Children 6 to 11 Years Old
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
1 other identifier
interventional
132
1 country
15
Brief Summary
A Phase 4 study to evaluate Qudexy XR for the prevention of migraine in children 6 to 11 years of age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2021
Longer than P75 for phase_4
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2021
CompletedFirst Posted
Study publicly available on registry
February 10, 2021
CompletedStudy Start
First participant enrolled
February 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
January 27, 2025
January 1, 2025
5.5 years
February 5, 2021
January 22, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Placebo
PLACEBO COMPARATORQudexy XR
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Upsher-Smith Clinical Trial Site #5
Birmingham, Alabama, 35205, United States
Upsher-Smith Clinical Trial Site #15
La Jolla, California, 92093, United States
Upsher-Smith Clinical Trials Site #3
Aurora, Colorado, 80045, United States
Upsher-Smith Clinical Trial Site #1
Stamford, Connecticut, 06901, United States
Upsher-Smith Clinical Trial Site #12
Loxahatchee Groves, Florida, 33470, United States
Upsher-Smith Clinical Trial Site #8
Orlando, Florida, 32789, United States
Upsher-Smith Clinical Trial Site #14
Tampa, Florida, 33620, United States
Upsher-Smith Clinical Trial Site #2
Ann Arbor, Michigan, 48104, United States
Upsher-Smith Clinical Trial Site #11
Jackson, Mississippi, 39216, United States
Upsher-Smith Clinical Trial Site #10
Bridgeton, Missouri, 63044, United States
Upsher-Smith Clinical Trial Site #4
Cincinnati, Ohio, 45229, United States
Upsher-Smith Clinical Trial Site #6
Portland, Oregon, 97239, United States
Upsher-Smith Clinical Trials Site #7
Springfield, Oregon, 97477, United States
Upsher-Smith Clinical Trial Site #13
McAllen, Texas, 78503, United States
Upsher-Smith Clinical Trial Site #9
Huntington, West Virginia, 25701, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2021
First Posted
February 10, 2021
Study Start
February 19, 2021
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
January 27, 2025
Record last verified: 2025-01