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A Phase 4 study to evaluate Qudexy XR for the prevention of migraine in children 6 to 11 years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Qudexy XR | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qudexy XR | Drug | Extended-Release Capsule |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| PPD Laboratories | Contact | 1-877-302-2879 | uslinfo@upsher-smith.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Upsher-Smith Clinical Trial Site #5 | Withdrawn | Birmingham | Alabama | 35205 | United States | |
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Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study
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| Drug |
Qudexy XR Matching capsules |
|
| Upsher-Smith Clinical Trial Site #15 |
| Recruiting |
| La Jolla |
| California |
| 92093 |
| United States |
| Upsher-Smith Clinical Trials Site #3 | Withdrawn | Aurora | Colorado | 80045 | United States |
| Upsher-Smith Clinical Trial Site #1 | Completed | Stamford | Connecticut | 06901 | United States |
| Upsher-Smith Clinical Trial Site #12 | Withdrawn | Loxahatchee Groves | Florida | 33470 | United States |
| Upsher-Smith Clinical Trial Site #8 | Withdrawn | Orlando | Florida | 32789 | United States |
| Upsher-Smith Clinical Trial Site #14 | Recruiting | Tampa | Florida | 33620 | United States |
| Upsher-Smith Clinical Trial Site #2 | Withdrawn | Ann Arbor | Michigan | 48104 | United States |
| Upsher-Smith Clinical Trial Site #11 | Withdrawn | Jackson | Mississippi | 39216 | United States |
| Upsher-Smith Clinical Trial Site #10 | Withdrawn | Bridgeton | Missouri | 63044 | United States |
| Upsher-Smith Clinical Trial Site #4 | Recruiting | Cincinnati | Ohio | 45229 | United States |
| Upsher-Smith Clinical Trial Site #6 | Recruiting | Portland | Oregon | 97239 | United States |
| Upsher-Smith Clinical Trials Site #7 | Recruiting | Springfield | Oregon | 97477 | United States |
| Upsher-Smith Clinical Trial Site #13 | Withdrawn | McAllen | Texas | 78503 | United States |
| Upsher-Smith Clinical Trial Site #9 | Recruiting | Huntington | West Virginia | 25701 | United States |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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