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Recruiting Phase 4

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

NCT04748601 · tracked via the Priya Life Science USA tracker
Sponsor
Upsher-Smith Laboratories
Phase
Phase 4
Started
2021-02-19
Last updated
2025-01-27

Condition(s) studied

Migraine Disorders

Investigational drug(s) / intervention(s)

Qudexy XRPlacebo

Qudexy XR: Extended-Release Capsule

Placebo: Qudexy XR Matching capsules

Study summary

A Phase 4 study to evaluate Qudexy XR for the prevention of migraine in children 6 to 11 years of age.

Eligibility

Sex
ALL
Min age
6 Years
Max age
11 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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

Trial sites (15)

FacilityCityRegionStatus
Upsher-Smith Clinical Trial Site #5 Birmingham Alabama Withdrawn
Upsher-Smith Clinical Trial Site #15 La Jolla California Recruiting
Upsher-Smith Clinical Trials Site #3 Aurora Colorado Withdrawn
Upsher-Smith Clinical Trial Site #1 Stamford Connecticut Completed
Upsher-Smith Clinical Trial Site #12 Loxahatchee Groves Florida Withdrawn
Upsher-Smith Clinical Trial Site #8 Orlando Florida Withdrawn
Upsher-Smith Clinical Trial Site #14 Tampa Florida Recruiting
Upsher-Smith Clinical Trial Site #2 Ann Arbor Michigan Withdrawn
Upsher-Smith Clinical Trial Site #11 Jackson Mississippi Withdrawn
Upsher-Smith Clinical Trial Site #10 Bridgeton Missouri Withdrawn
Upsher-Smith Clinical Trial Site #4 Cincinnati Ohio Recruiting
Upsher-Smith Clinical Trial Site #6 Portland Oregon Recruiting
Upsher-Smith Clinical Trials Site #7 Springfield Oregon Recruiting
Upsher-Smith Clinical Trial Site #13 McAllen Texas Withdrawn
Upsher-Smith Clinical Trial Site #9 Huntington West Virginia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04748601 on ClinicalTrials.gov ↗ ← All trials in the USA