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

January 22, 2025 updated by: Upsher-Smith Laboratories

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

132

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Withdrawn
        • Upsher-Smith Clinical Trial Site #5
    • California
      • La Jolla, California, United States, 92093
        • Recruiting
        • Upsher-Smith Clinical Trial Site #15
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Withdrawn
        • Upsher-Smith Clinical Trials Site #3
    • Connecticut
      • Stamford, Connecticut, United States, 06901
        • Completed
        • Upsher-Smith Clinical Trial Site #1
    • Florida
      • Loxahatchee Groves, Florida, United States, 33470
        • Withdrawn
        • Upsher-Smith Clinical Trial Site #12
      • Orlando, Florida, United States, 32789
        • Withdrawn
        • Upsher-Smith Clinical Trial Site #8
      • Tampa, Florida, United States, 33620
        • Recruiting
        • Upsher-Smith Clinical Trial Site #14
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Withdrawn
        • Upsher-Smith Clinical Trial Site #2
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Withdrawn
        • Upsher-Smith Clinical Trial Site #11
    • Missouri
      • Bridgeton, Missouri, United States, 63044
        • Withdrawn
        • Upsher-Smith Clinical Trial Site #10
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Upsher-Smith Clinical Trial Site #4
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Upsher-Smith Clinical Trial Site #6
      • Springfield, Oregon, United States, 97477
        • Recruiting
        • Upsher-Smith Clinical Trials Site #7
    • Texas
      • McAllen, Texas, United States, 78503
        • Withdrawn
        • Upsher-Smith Clinical Trial Site #13
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • Recruiting
        • Upsher-Smith Clinical Trial Site #9

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 7 years (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Qudexy XR Matching capsules
Experimental: Qudexy XR
Drug: Qudexy XR
Extended-Release Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 16 Weeks
16 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Upsher-Smith Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2021

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

February 5, 2021

First Submitted That Met QC Criteria

February 5, 2021

First Posted (Actual)

February 10, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 22, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P255-501

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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