Overview

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

Status:
Recruiting
Trial end date:
2023-10-01
Target enrollment:
0
Participant gender:
All
Summary
A Phase 4 study to evaluate Qudexy XR for the prevention of migraine in children 6 to 11 years of age.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Upsher-Smith Laboratories
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.