The purpose of this study is to evaluate the efficacy and safety of eptinezumab administered intravenously in participants experiencing an acute attack of migraine.
This will be a parallel group, double-blind, randomized, placebo-controlled study assessing the efficacy of eptinezumab for acute migraine, defined as an active intercurrent migraine occurring in those participants who are candidates for preventive therapy. Participants will be randomized to receive a single dose of eptinezumab or placebo in a 1:1 ratio. The total study duration will be approximately 4 to 12 weeks, including up to an 8-week screening period and 4-week of safety follow-up, with clinic visits occurring on Screening, Day 0 (dosing day), and Week 4.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
485
Injection for IV administration
Injection for IV administration
Time to Headache Pain Freedom
Time to headache pain freedom defined as the time that the participant reported freedom of pain, meaning their headache pain had gone from moderate to severe at baseline to no pain.
Time frame: Up to 48 hours postdose
Time to Absence of Most Bothersome Symptom (MBS)
Time to absence of most bothersome symptom defined as the time that the participant reported absence of MBS (of nausea, photophobia, or phonophobia).
Time frame: Up to 48 hours postdose
Headache Pain Freedom at 2 Hours
Number of participants with freedom from headache pain at 2 hours postdose are reported. Freedom from headache pain meaning that the headache pain that had gone from moderate to severe at baseline to no pain with no administration of rescue medications.
Time frame: 2 hours
Absence of MBS at 2 Hours
Number of participants with absence of MBS (of nausea, photophobia, or phonophobia) at 2 hours postdose are reported.
Time frame: 2 hours
Headache Pain Freedom at 4 Hours
Number of participants with freedom from headache pain at 4 hours postdose are reported. Freedom from headache pain meaning that the headache pain that had gone from moderate to severe at baseline to no pain with no administration of rescue medications.
Time frame: 4 hours
Absence of MBS at 4 Hours
Number of participants with absence of MBS (of nausea, photophobia, or phonophobia) at 4 hours postdose are reported.
Time frame: 4 hours
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Alabama Clinical Therapeutics
Birmingham, Alabama, United States
Arizona Research Center
Phoenix, Arizona, United States
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States
Advanced Research Center
Anaheim, California, United States
The Neurology Center of Southern California - Carlsbad
Carlsbad, California, United States
Excell research Inc
Oceanside, California, United States
Anderson Clinical Research
Redlands, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Denver Neurological Clinic - Denver
Denver, Colorado, United States
Coastal Connecticut Research LLC
New London, Connecticut, United States
...and 47 more locations
Use of Rescue Medication Within the First 24 Hours
Rescue medication was defined as any medication to treat migraine or migraine-associated symptoms, which could have been provided to the participant any time after 2 hours post-start of infusion. Use of rescue medication was captured in the eDiary. Number of participants who used rescue medication up to 24 hours postdose are reported.
Time frame: Up to 24 hours postdose