Tests Qudexy XR for preventing migraine in children aged 6 to 11
Tests Qudexy XR against a placebo to prevent migraines in children aged 6 to 11.
Plain-language title generated from the registry record
Registry title: Qudexy XR for the Prevention of Migraine in Children 6 to 11 Years Old
Key facts
- Where
- Ann Arbor, Aurora, Birmingham, Bridgeton, Cincinnati, Huntington, Jackson, La Jolla, Loxahatchee Groves, McAllen, Orlando, Portland, Springfield, Stamford, and Tampa, United StatesSee the 15 sites
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 11 years old?
Source: NCT04748601, who can take part
Where in United States
- Ann ArborAnn Arbor, United StatesNo longer taking part
- AuroraAurora, United StatesNo longer taking part
- BirminghamBirmingham, United StatesNo longer taking part
- BridgetonBridgeton, United StatesNo longer taking part
- CincinnatiCincinnati, United StatesTaking people
- HuntingtonHuntington, United StatesTaking people
- JacksonJackson, United StatesNo longer taking part
- La JollaLa Jolla, United StatesTaking people
- Loxahatchee GrovesLoxahatchee Groves, United StatesNo longer taking part
- McAllenMcAllen, United StatesNo longer taking part
- OrlandoOrlando, United StatesNo longer taking part
- PortlandPortland, United StatesTaking people
- SpringfieldSpringfield, United StatesTaking people
- StamfordStamford, United StatesNo longer taking part
- TampaTampa, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Upsher-Smith Laboratories
- Trial code
- NCT04748601
- Record updated
- 27 January 2025
- Original description
A Phase 4 study to evaluate Qudexy XR for the prevention of migraine in children 6 to 11 years of age.Read full original descriptionShow less
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 4 Study to Evaluate the Efficacy and Safety of Qudexy(R) XR in the Prevention of Migraine in Children 6 to 11 Years of Age
A Phase 4 study to evaluate Qudexy XR for the prevention of migraine in children 6 to 11 years of age.
Inclusion: Subject is a female or male 6 to 11 years of age, inclusive, at Visit 1 (Screening); 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; 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]); Subject had ≥8 self-reported headache days in the 28 days prior to Screening; 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: Subject is currently receiving treatment or has used Botulinum toxin (Botox®) within 3 months prior to Visit 1 (Screening); 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; 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; Subject has previously failed an adequate trial of >3 migraine preventative medications; Subject is currently using an investigational drug or device or has used such within 30 days prior to Visit 1; Subject has a known history of allergic reaction to topiramate or any excipient in Qudexy XR; Subject has a diagnosis or history of disease that may interfere with safety or evaluation of the study drug; Subject has continuous migraines, defined as an unrelenting headache for a 28-day period; Subject has begun menses and any of the following:; Subject has tested positive for pregnancy; OR; Subject is pregnant, planning pregnancy, or lactating; OR; 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.