Tandem OnabotulinumtoxinA Galcanezumab Emerging Therapeutic Headache Elimination Research Study
Status:
Not yet recruiting
Trial end date:
2024-10-31
Target enrollment:
Participant gender:
Summary
This is a multicenter, double-blind, placebo-controlled study assessing the effectiveness of
Galcanezumab as an add-on therapy for Migraine participants on a stable migraine prophylaxis
regimen including Botox with or without one other migraine prophylaxis agent (BMPT), who have
persistent unmet need. The study population will consist of approximately 150 participants
ages 18-65 who report at least a 30% reduction in monthly migraine days from BMPT and still
experience an average of ≥ 6 migraine days per month, following International Classification
of Headache Disorders (ICHD-3) criteria. Subjects should be stable on at least 2, but no more
than 8, consecutive injection cycles of Botox. Overall migraine day reduction will be
assessed in the participants based on participant self-report (via daily electronic diaries)
and medical record review.