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

Migraine Disorders Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04748601
• Other study ID #: P255-501
• Status: Recruiting
• Phase: Phase 4
• Start date: February 19, 2021
• Est. completion date: September 2026

Study information

• Verified date: June 2023
• Source: Upsher-Smith Laboratories
• Contact: PPD Laboratories
• Phone: 1-877-302-2879
• Email: uslinfo[@]upsher-smith.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Drug:
• Qudexy XR
Extended-Release Capsule
• Placebo
Qudexy XR Matching capsules

Locations

Country	Name	City	State
United States	Upsher-Smith Clinical Trial Site #2	Ann Arbor	Michigan
United States	Upsher-Smith Clinical Trials Site #3	Aurora	Colorado
United States	Upsher-Smith Clinical Trial Site #5	Birmingham	Alabama
United States	Upsher-Smith Clinical Trial Site #10	Bridgeton	Missouri
United States	Upsher-Smith Clinical Trial Site #4	Cincinnati	Ohio
United States	Upsher-Smith Clinical Trial Site #9	Huntington	West Virginia
United States	Upsher-Smith Clinical Trial Site #11	Jackson	Mississippi
United States	Upsher-Smith Clinical Trial Site #15	La Jolla	California
United States	Upsher-Smith Clinical Trial Site #12	Loxahatchee Groves	Florida
United States	Upsher-Smith Clinical Trial Site #13	McAllen	Texas
United States	Upsher-Smith Clinical Trial Site #8	Orlando	Florida
United States	Upsher-Smith Clinical Trial Site #6	Portland	Oregon
United States	Upsher-Smith Clinical Trials Site #7	Springfield	Oregon
United States	Upsher-Smith Clinical Trial Site #1	Stamford	Connecticut
United States	Upsher-Smith Clinical Trial Site #14	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Upsher-Smith Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		16 Weeks