Actively Recruiting
Study of Qudexy XR Capsules to Prevent Migraines in Children Ages 6 to 11 Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Safety and Effectiveness
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
Researchers are evaluating Qudexy XR, an extended-release capsule, for preventing migraines in children aged 6 to 11 years. This Phase 4 trial compares Qudexy XR to a placebo to study its effectiveness and safety in reducing the number of headache days in young children who have a history of migraine headaches. Participants will receive either Qudexy XR or matching placebo capsules during the study. The treatment is monitored over an 8-week maintenance period following a 28-day run-in phase. The study measures changes in the monthly number of headache days based on headache diaries kept by the children or their caregivers. Throughout the study, participants will track their headaches daily using a diary to record headache frequency. Researchers will assess the change in headache days from baseline to the maintenance period. The total participation duration includes a run-in period followed by 16 weeks of observation to evaluate the treatment's impact on migraine prevention and monitor safety.
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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