RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2021-02-19

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04748601

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.

Ages Eligible for Study:6 Years to 11 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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

Study Contact

PPD Laboratories

CONTACT

1-877-302-2879

uslinfo@upsher-smith.com

Study Locations (Sites)

Upsher-Smith Clinical Trial Site #5

Birmingham, Alabama, 35205

United States

Upsher-Smith Clinical Trial Site #15

La Jolla, California, 92093

United States

Upsher-Smith Clinical Trials Site #3

Aurora, Colorado, 80045

United States

Upsher-Smith Clinical Trial Site #1

Stamford, Connecticut, 06901

United States

Upsher-Smith Clinical Trial Site #12

Loxahatchee Groves, Florida, 33470

United States

Upsher-Smith Clinical Trial Site #8

Orlando, Florida, 32789

United States

Upsher-Smith Clinical Trial Site #14

Tampa, Florida, 33620

United States

Upsher-Smith Clinical Trial Site #2

Ann Arbor, Michigan, 48104

United States

Upsher-Smith Clinical Trial Site #11

Jackson, Mississippi, 39216

United States

Upsher-Smith Clinical Trial Site #10

Bridgeton, Missouri, 63044

United States

Upsher-Smith Clinical Trial Site #4

Cincinnati, Ohio, 45229

United States

Upsher-Smith Clinical Trial Site #6

Portland, Oregon, 97239

United States

Upsher-Smith Clinical Trials Site #7

Springfield, Oregon, 97477

United States

Upsher-Smith Clinical Trial Site #13

McAllen, Texas, 78503

United States

Upsher-Smith Clinical Trial Site #9

Huntington, West Virginia, 25701

United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2021-02-19

Study Completion Date2026-09

Study Record Updates

Study Start Date2021-02-19

Study Completion Date2026-09

Terms related to this study

Additional Relevant MeSH Terms

Migraine Disorders