This study will be conducted to evaluate the safety and efficacy of sumatriptan nasal powder (AVP-825) compared to placebo in the acute treatment of migraine in adolescent participants, 12 through 17 years of age.
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating AVP-825 for the acute treatment of migraine with or without aura in adolescent subjects (12 to 17 years old).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
159
nasal powder administered via nosepiece
lactose monohydrate powder administered via nosepiece
Number of Participants Who Were Headache Pain Free at 120 Minutes After Treatment
Participants will self-report the severity of their headache.
Time frame: 120 minutes
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Phoenix Children's Hospital
Phoenix, Arizona, United States
Advanced Research Center
Anaheim, California, United States
Axis Clinical Trial Network
Los Angeles, California, United States
Axis Clinical Trial Network
Los Angeles, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Alpine Clinical Research Center, Inc.
Boulder, Colorado, United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, United States
Mountain View Clinical Research, Inc.
Denver, Colorado, United States
New England Institute for Neurology and Headache
Stamford, Connecticut, United States
International Research Partners, LLC
Doral, Florida, United States
...and 30 more locations