Qudexy XR for Migraine Prevention in Children

This study is testing Qudexy XR, an extended-release capsule, to see if it can help prevent migraine headaches in children aged 6 to 11 years old. Some children will receive Qudexy XR, while others will receive a placebo (an inactive capsule that looks the same). The main goal is to see if Qudexy XR reduces the number of headache days over an 8-week period, compared to the start of the study. To join, children need to be between 6 and 11 years old, weigh between 17 and 50 kg, and have had migraines for at least 6 months. The study plans to enroll 132 children, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive either Qudexy XR or a placebo. It aims to enroll 132 children.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 16 weeks, suggesting follow-up for at least that duration.

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NCT04748601

Qudexy XR for the Prevention of Migraine in Children 6 to 11 Years Old

Recruiting
PHASE4Ages 6–11InterventionalTreatment
Upsher-Smith Laboratories
~132 participants
Updated 2025-01-27 on ClinicalTrials.gov
What's tested:Qudexy XRPlacebo

At a glance

Recruiting sites
6 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over 16 Weeks
Migraine Disorders
15 sites across 12 states
Florida3
Oregon2
Alabama1
California1
Colorado1
Connecticut1
Michigan1
Mississippi1

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  • 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