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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
132

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 19, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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