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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04748601
Recruitment Status : Recruiting
First Posted : February 10, 2021
Last Update Posted : December 22, 2022
Sponsor:
Information provided by (Responsible Party):
Upsher-Smith Laboratories

Study Description
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Brief Summary:
A Phase 4 study to evaluate Qudexy XR for the prevention of migraine in children 6 to 11 years of age.

Condition or disease Intervention/treatment Phase
Migraine Disorders Drug: Qudexy XR Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 19, 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Qudexy XR Matching capsules
Experimental: Qudexy XR Drug: Qudexy XR
Extended-Release Capsule


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04748601


Contacts
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Contact: PPD Laboratories 1-877-302-2879 uslinfo@upsher-smith.com

Locations
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United States, Alabama
Upsher-Smith Clinical Trial Site #5 Recruiting
Birmingham, Alabama, United States, 35205
Upsher-Smith Clinical Trial Site #9 Recruiting
Mobile, Alabama, United States, 36688
United States, California
Upsher-Smith Clinical Trial Site #15 Not yet recruiting
La Jolla, California, United States, 92093
United States, Colorado
Upsher-Smith Clinical Trials Site #3 Withdrawn
Aurora, Colorado, United States, 80045
United States, Connecticut
Upsher-Smith Clinical Trial Site #1 Recruiting
Stamford, Connecticut, United States, 06901
United States, Florida
Upsher-Smith Clinical Trial Site #12 Recruiting
Loxahatchee Groves, Florida, United States, 33470
Upsher-Smith Clinical Trial Site #8 Recruiting
Orlando, Florida, United States, 32789
Upsher-Smith Clinical Trial Site #14 Not yet recruiting
Tampa, Florida, United States, 33620
United States, Michigan
Upsher-Smith Clinical Trial Site #2 Withdrawn
Ann Arbor, Michigan, United States, 48104
United States, Mississippi
Upsher-Smith Clinical Trial Site #11 Withdrawn
Jackson, Mississippi, United States, 39216
United States, Missouri
Upsher-Smith Clinical Trial Site #10 Recruiting
Bridgeton, Missouri, United States, 63044
United States, Ohio
Upsher-Smith Clinical Trial Site #4 Recruiting
Cincinnati, Ohio, United States, 45229
United States, Oregon
Upsher-Smith Clinical Trial Site #6 Recruiting
Portland, Oregon, United States, 97239
Upsher-Smith Clinical Trials Site #7 Recruiting
Springfield, Oregon, United States, 97477
United States, Texas
Upsher-Smith Clinical Trial Site #13 Recruiting
Houston, Texas, United States, 77084
Sponsors and Collaborators
Upsher-Smith Laboratories
More Information
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Responsible Party: Upsher-Smith Laboratories
ClinicalTrials.gov Identifier: NCT04748601    
Other Study ID Numbers: P255-501
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: December 22, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases