The purpose of this study is to compare the sustained long-term benefit between two treatment paradigms of migraine prophylactic agents (erenumab versus a control arm of oral prophylactics) in episodic migraine patients who have previously failed 1 to 2 prophylactic migraine treatments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
621
Subcutaneous Injection
SOC Oral Tablet/Capsule
Number of Participants Who Completed Initially Assigned Treatment and Achieved at Least a 50% Reduction From Baseline in Monthly Migraine Days at Month 12
A migraine day was defined as any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined as a migraine with or without aura, lasting for ≥ 30 minutes, and meeting at least one of the following criteria: 1. ≥2 of the following pain features: * Unilateral * Throbbing * Moderate to severe * Exacerbated with exercise/physical activity 2. ≥1 of the following associated symptoms: * Nausea and/or vomiting * Photophobia and phonophobia If the participant took a migraine-specific medication (ie, triptan or ergotamine) during aura, or to treat a headache on a calendar day, then it was counted as a migraine day regardless of the duration and pain features/associated symptoms. In addition to achieving at least a 50% reduction from baseline in monthly migraine days, participants must have also completed their initially assigned treatment through Month 12.
Time frame: Baseline and Month 12
Number of Participants Who Completed Initially Assigned Treatment at Month 12
Time frame: Month 12
Cumulative Mean Change From Baseline on the Monthly Migraine Days to Week 52
A migraine day was defined as any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). The mean of monthly migraine days was obtained cumulatively every 4 weeks across 52 weeks (for example, at Week 8 the mean will be based on data from Week 1 to Week 8; and at Week 12 the mean will be based on data from Week 1 to Week 12). The cumulative mean change from baseline in monthly migraine days was derived using difference between cumulative average of each month and baseline monthly migraine days.
Time frame: Baseline and Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, and Week 52
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Stanford Headache Center
Stanford, California, United States
Yale Center for Clinical Research
New Haven, Connecticut, United States
New England Institute for Neurology and Headache
Stamford, Connecticut, United States
George Washington Hospital
Washington D.C., District of Columbia, United States
University of Miami Headache Division
Miami, Florida, United States
Premier Research Institute
West Palm Beach, Florida, United States
Diamond Headache Clinic
Chicago, Illinois, United States
Robbins Headache Clinic
Riverwoods, Illinois, United States
Medvadis
Watertown, Massachusetts, United States
New England Regional Headache Center, Inc
Worcester, Massachusetts, United States
...and 102 more locations
Number of Responders as Measured by the Patient's Global Impression of Change (PGIC) Scale at Week 52
The PGIC scale consists of one item which measures the participants' perception of change in their condition relative to the beginning of the study. Responses are rated on a 7-item response scale ranging from very much improved (7) to no change or worsened condition (1). A responder was defined as a participant with a PGIC score of at least 5 (5=moderately better, 6=better, 7=a great deal better), at Week 52 for participants who completed the treatment period at Week 52 on the initially assigned treatment.
Time frame: Baseline and Week 52