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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Upsher-Smith Laboratories
Study ID
NCT04748601
Phase
PHASE4
Status
Recruiting
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Conditions

  • Migraine Disorders

Eligibility Criteria

Sex
ALL
Age
6 Years - 11 Years
Healthy Volunteers
Not accepted

Interventions

  • Qudexy XR — DRUG
    Extended-Release Capsule
  • Placebo — DRUG
    Qudexy XR Matching capsules

Study Details

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

Key Dates

Start date
Feb 19, 2021
Status verified
Jan 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
132 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
  • Experimental: Qudexy XR

Primary Outcome Measure

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 ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
Upsher-Smith Clinical Trial Site #5BirminghamAlabama35205-
Upsher-Smith Clinical Trial Site #15La JollaCalifornia92093-
Upsher-Smith Clinical Trials Site #3AuroraColorado80045-
Upsher-Smith Clinical Trial Site #1StamfordConnecticut06901-
Upsher-Smith Clinical Trial Site #12Loxahatchee GrovesFlorida33470-
Upsher-Smith Clinical Trial Site #8OrlandoFlorida32789-
Upsher-Smith Clinical Trial Site #14TampaFlorida33620-
Upsher-Smith Clinical Trial Site #2Ann ArborMichigan48104-
Upsher-Smith Clinical Trial Site #11JacksonMississippi39216-
Upsher-Smith Clinical Trial Site #10BridgetonMissouri63044-
Upsher-Smith Clinical Trial Site #4CincinnatiOhio45229-
Upsher-Smith Clinical Trial Site #6PortlandOregon97239-
Upsher-Smith Clinical Trials Site #7SpringfieldOregon97477-
Upsher-Smith Clinical Trial Site #13McAllenTexas78503-
Upsher-Smith Clinical Trial Site #9HuntingtonWest Virginia25701-

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