Qudexy XR for the Prevention of Migraine in Children 6 to 11 Years Old
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 6 Years to 11 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
A Phase 4 study to evaluate Qudexy XR for the prevention of migraine in children 6 to 11 years of age.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official 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.
Study sites (15)
AL
- Upsher-Smith Clinical Trial Site #5 · Birmingham, AL 35205More trials in Birmingham
CA
- Upsher-Smith Clinical Trial Site #15 · La Jolla, CA 92093More trials in La Jolla
CO
- Upsher-Smith Clinical Trials Site #3 · Aurora, CO 80045More trials in Aurora
CT
- Upsher-Smith Clinical Trial Site #1 · Stamford, CT 06901More trials in Stamford
FL
- Upsher-Smith Clinical Trial Site #12 · Loxahatchee Groves, FL 33470More trials in Loxahatchee Groves
- Upsher-Smith Clinical Trial Site #8 · Orlando, FL 32789More trials in Orlando
- Upsher-Smith Clinical Trial Site #14 · Tampa, FL 33620More trials in Tampa
MI
- Upsher-Smith Clinical Trial Site #2 · Ann Arbor, MI 48104More trials in Ann Arbor
MO
- Upsher-Smith Clinical Trial Site #10 · Bridgeton, MO 63044More trials in Bridgeton
MS
- Upsher-Smith Clinical Trial Site #11 · Jackson, MS 39216More trials in Jackson
OH
- Upsher-Smith Clinical Trial Site #4 · Cincinnati, OH 45229More trials in Cincinnati
OR
- Upsher-Smith Clinical Trial Site #6 · Portland, OR 97239More trials in Portland
- Upsher-Smith Clinical Trials Site #7 · Springfield, OR 97477More trials in Springfield
TX
- Upsher-Smith Clinical Trial Site #13 · McAllen, TX 78503More trials in McAllen
WV
- Upsher-Smith Clinical Trial Site #9 · Huntington, WV 25701More trials in Huntington