NCT04748601 Qudexy XR for the Prevention of Migraine in Children 6 to 11 Years Old
| NCT ID | NCT04748601 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Upsher-Smith Laboratories |
| Condition | Migraine Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 132 participants |
| Start Date | 2021-02-19 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 132 participants in total. It began in 2021-02-19 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A Phase 4 study to evaluate Qudexy XR for the prevention of migraine in children 6 to 11 years of age.
Eligibility Criteria
Inclusion Criteria: 1. Subject is a female or male 6 to 11 years of age, inclusive, at Visit 1 (Screening) 2. 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 3. 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 \[ICHD 3\]). 4. Subject had ≥8 self-reported headache days in the 28 days prior to Screening. 5. 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. Exclusion Criteria: 1. Subject has continuous migraines, defined as an unrelenting headache for a 28-day period. 2. Subject is currently receiving treatment or has used Botulinum toxin (Botox®) within 3 months prior to Visit 1 (Screening). 3. 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. 4. 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. 5. Subject has previously failed an adequate trial of \>3 migraine preventative medications. 6. Subject has a known history of allergic reaction to topiramate or any excipient in Qudexy XR. 7. Subject has a diagnosis or history of disease that may interfere with safety or evaluation of the study drug. 8. Subject is currently using an investigational drug or device or has used such within 30 days prior to Visit 1. 9. Subject has begun menses and any of the following: 1. Subject has tested positive for pregnancy; OR 2. Subject is pregnant, planning pregnancy, or lactating; OR 3. 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 & Investigator
Frequently Asked Questions
Who can join the NCT04748601 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 11 Years, studying Migraine Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04748601 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04748601 currently recruiting?
Yes, NCT04748601 is actively recruiting participants. Contact the research team at uslinfo@upsher-smith.com for enrollment information.
Where is the NCT04748601 trial being conducted?
This trial is being conducted at Birmingham, United States, La Jolla, United States, Aurora, United States, Stamford, United States and 11 additional locations.
Who is sponsoring the NCT04748601 clinical trial?
NCT04748601 is sponsored by Upsher-Smith Laboratories. The trial plans to enroll 132 participants.
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