Actively Recruiting
Qudexy XR for the Prevention of Migraine in Children 6 to 11 Years Old
Led by Upsher-Smith Laboratories · Updated on 2025-01-27
132
Participants Needed
15
Research Sites
288 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase 4 study to evaluate Qudexy XR for the prevention of migraine in children 6 to 11 years of age.
CONDITIONS
Official Title
Qudexy XR for the Prevention of Migraine in Children 6 to 11 Years Old
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child is male or female aged 6 to 11 years at screening
- Child weighs at least 17.0 kg and less than 50.0 kg at screening
- Child has at least a 6-month history of migraine headaches with or without aura
- Child had 8 or more self-reported headache days in the 28 days before screening
- Child has a PedMIDAS score greater than 10 and less than 140 indicating mild to extreme migraine-related disability
You will not qualify if you...
- Child has continuous migraines lasting 28 days without relief
- Child has used Botulinum toxin (Botox) within 3 months prior to screening
- Child is using migraine prevention medication and changed dose within 28 days before screening or will not avoid changes during the study
- Child previously failed a 3-month or longer trial of topiramate for migraine prevention due to lack of effect or side effects
- Child previously failed trials of more than 3 migraine preventive medications
- Child has known allergy to topiramate or any ingredient in Qudexy XR
- Child has any disease that may affect safety or study evaluation
- Child is currently or recently (within 30 days) using investigational drugs or devices
- Female child who has started menstruation and is pregnant, planning pregnancy, lactating, or taking oral hormonal contraceptives and cannot switch to another effective contraceptive method
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Upsher-Smith Clinical Trial Site #5
Birmingham, Alabama, United States, 35205
Withdrawn
2
Upsher-Smith Clinical Trial Site #15
La Jolla, California, United States, 92093
Actively Recruiting
3
Upsher-Smith Clinical Trials Site #3
Aurora, Colorado, United States, 80045
Withdrawn
4
Upsher-Smith Clinical Trial Site #1
Stamford, Connecticut, United States, 06901
Completed
5
Upsher-Smith Clinical Trial Site #12
Loxahatchee Groves, Florida, United States, 33470
Withdrawn
6
Upsher-Smith Clinical Trial Site #8
Orlando, Florida, United States, 32789
Withdrawn
7
Upsher-Smith Clinical Trial Site #14
Tampa, Florida, United States, 33620
Actively Recruiting
8
Upsher-Smith Clinical Trial Site #2
Ann Arbor, Michigan, United States, 48104
Withdrawn
9
Upsher-Smith Clinical Trial Site #11
Jackson, Mississippi, United States, 39216
Withdrawn
10
Upsher-Smith Clinical Trial Site #10
Bridgeton, Missouri, United States, 63044
Withdrawn
11
Upsher-Smith Clinical Trial Site #4
Cincinnati, Ohio, United States, 45229
Actively Recruiting
12
Upsher-Smith Clinical Trial Site #6
Portland, Oregon, United States, 97239
Actively Recruiting
13
Upsher-Smith Clinical Trials Site #7
Springfield, Oregon, United States, 97477
Actively Recruiting
14
Upsher-Smith Clinical Trial Site #13
McAllen, Texas, United States, 78503
Withdrawn
15
Upsher-Smith Clinical Trial Site #9
Huntington, West Virginia, United States, 25701
Actively Recruiting
Research Team
P
PPD Laboratories
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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