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

Primary Purpose

Migraine Disorders

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Qudexy XR
Placebo
Sponsored by
Upsher-Smith Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Disorders

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Upsher-Smith Clinical Trial Site #5Recruiting
  • Upsher-Smith Clinical Trial Site #15Recruiting
  • Upsher-Smith Clinical Trials Site #3
  • Upsher-Smith Clinical Trial Site #1Recruiting
  • Upsher-Smith Clinical Trial Site #12Recruiting
  • Upsher-Smith Clinical Trial Site #8Recruiting
  • Upsher-Smith Clinical Trial Site #14Recruiting
  • Upsher-Smith Clinical Trial Site #2
  • Upsher-Smith Clinical Trial Site #11
  • Upsher-Smith Clinical Trial Site #10Recruiting
  • Upsher-Smith Clinical Trial Site #4Recruiting
  • Upsher-Smith Clinical Trial Site #6Recruiting
  • Upsher-Smith Clinical Trials Site #7Recruiting
  • Upsher-Smith Clinical Trial Site #13Recruiting
  • Upsher-Smith Clinical Trial Site #9Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Qudexy XR

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 5, 2021
Last Updated
June 14, 2023
Sponsor
Upsher-Smith Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT04748601
Brief Title
Qudexy XR for the Prevention of Migraine in Children 6 to 11 Years Old
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 19, 2021 (Actual)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Upsher-Smith Laboratories

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Qudexy XR
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Qudexy XR
Intervention Description
Extended-Release Capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Qudexy XR Matching capsules
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is a female or male 6 to 11 years of age, inclusive, at Visit 1 (Screening) 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 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]). Subject had ≥8 self-reported headache days in the 28 days prior to Screening. 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: Subject has continuous migraines, defined as an unrelenting headache for a 28-day period. Subject is currently receiving treatment or has used Botulinum toxin (Botox®) within 3 months prior to Visit 1 (Screening). 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. 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. Subject has previously failed an adequate trial of >3 migraine preventative medications. Subject has a known history of allergic reaction to topiramate or any excipient in Qudexy XR. Subject has a diagnosis or history of disease that may interfere with safety or evaluation of the study drug. Subject is currently using an investigational drug or device or has used such within 30 days prior to Visit 1. Subject has begun menses and any of the following: Subject has tested positive for pregnancy; OR Subject is pregnant, planning pregnancy, or lactating; OR 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
PPD Laboratories
Phone
1-877-302-2879
Email
uslinfo@upsher-smith.com
Facility Information:
Facility Name
Upsher-Smith Clinical Trial Site #5
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Individual Site Status
Recruiting
Facility Name
Upsher-Smith Clinical Trial Site #15
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Name
Upsher-Smith Clinical Trials Site #3
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Withdrawn
Facility Name
Upsher-Smith Clinical Trial Site #1
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06901
Country
United States
Individual Site Status
Recruiting
Facility Name
Upsher-Smith Clinical Trial Site #12
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470
Country
United States
Individual Site Status
Recruiting
Facility Name
Upsher-Smith Clinical Trial Site #8
City
Orlando
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Individual Site Status
Recruiting
Facility Name
Upsher-Smith Clinical Trial Site #14
City
Tampa
State/Province
Florida
ZIP/Postal Code
33620
Country
United States
Individual Site Status
Recruiting
Facility Name
Upsher-Smith Clinical Trial Site #2
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Individual Site Status
Withdrawn
Facility Name
Upsher-Smith Clinical Trial Site #11
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Withdrawn
Facility Name
Upsher-Smith Clinical Trial Site #10
City
Bridgeton
State/Province
Missouri
ZIP/Postal Code
63044
Country
United States
Individual Site Status
Recruiting
Facility Name
Upsher-Smith Clinical Trial Site #4
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Name
Upsher-Smith Clinical Trial Site #6
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
Upsher-Smith Clinical Trials Site #7
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Individual Site Status
Recruiting
Facility Name
Upsher-Smith Clinical Trial Site #13
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Individual Site Status
Recruiting
Facility Name
Upsher-Smith Clinical Trial Site #9
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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