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Using Qudexy XR to prevent migraines in children aged 6 to 11

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

Phase 4 Interventional Upsher-Smith Laboratories · NCT04748601

This study is testing if Qudexy XR can help prevent migraines in children aged 6 to 11 who have a history of headaches.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment132 (estimated)
Ages6 Years to 11 Years
SexAll
SponsorUpsher-Smith Laboratories Industry-sponsored
Locations15 sites (Birmingham, Alabama and 14 other locations)
Trial IDNCT04748601 on ClinicalTrials.gov

What this trial studies

This Phase 4 clinical trial evaluates the effectiveness of Qudexy XR in preventing migraines in children aged 6 to 11 years. Participants must have a history of migraines and experience a certain number of headache days prior to screening. The study involves administering either Qudexy XR or a placebo to assess the impact on migraine frequency and severity. The trial aims to provide insights into the safety and efficacy of this treatment in a pediatric population.

Who should consider this trial

Good fit: Ideal candidates are children aged 6 to 11 who have a documented history of migraines and experience multiple headache days each month.

Not a fit: Patients with continuous migraines or those currently receiving certain migraine treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the frequency and severity of migraines in children, improving their quality of life.

How similar studies have performed: Other studies have explored migraine prevention in children, but the specific use of Qudexy XR in this age group is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Birmingham, Alabama and 14 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Migraine Disorders
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.