A Phase 4 interventional study of Qudexy XR and Placebo in Migraine Disorders, sponsored by Upsher-Smith Laboratories. Recruiting at 15 sites in United States. Open to participants aged 6 Years to 11 Years. Per ClinicalTrials.gov, last updated 2025-01-27.
Sponsored by Upsher-Smith Laboratories · Phase 4, Interventional, and Treatment
A Phase 4 study to evaluate Qudexy XR for the prevention of migraine in children 6 to 11 years of age.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's planned enrollment of 132 is above the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Upsher-Smith Laboratories is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subject has begun menses and any of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Placebo
Drug: Qudexy XR
Extended-Release Capsule
Qudexy XR Matching capsules
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.
Time frame: 16 Weeks
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Started Feb 2021 (actual). Primary completion is estimated for Sep 2026, 67 months after the start.
Of 28 industry-sponsored phase 4 interventional studies under Migraine Disorders, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 33. This study's planned 67 months is above that.
Counting every sponsor, half of 77 studies reached it within 27 months; a quarter within 17 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Topiramate
Upsher-Smith Laboratories