Abstract | BACKGROUND: METHODS: PROMISE-1 (NCT02559895; episodic migraine) and PROMISE-2 (NCT02974153; chronic migraine) were randomized, double-blind, placebo-controlled trials that evaluated eptinezumab for migraine prevention. In both studies, the primary outcome was the mean change from baseline in monthly migraine days over Weeks 1-12. Patients in this analysis included those who self-reported migraine with aura at screening. RESULTS: Of patients with episodic migraine, ∼75% reported a history of aura at screening; of patients with chronic migraine, ∼35% reported a history of aura. Changes in monthly migraine days over Weeks 1-12 were -4.0 (100 mg) and -4.2 (300 mg) with eptinezumab versus -3.1 with placebo in patients with episodic migraine with aura, and were -7.1 (100 mg) and -7.6 (300 mg) with eptinezumab versus -6.0 with placebo in patients with chronic migraine with aura. Treatment-emergent adverse events were reported by 56.0% (100 mg), 57.4% (300 mg), and 55.4% (placebo) of patients. CONCLUSIONS: The preventive migraine efficacy of eptinezumab in patients in the PROMISE studies who self-reported aura was comparable to the overall study populations, demonstrating a similarly favorable safety and tolerability profile.Trial registration: ClinicalTrials.gov Identifiers: NCT02559895 and NCT02974153.
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Authors | Messoud Ashina, Peter McAllister, Roger Cady, Joe Hirman, Anders Ettrup |
Journal | Cephalalgia : an international journal of headache
(Cephalalgia)
Vol. 42
Issue 8
Pg. 696-704
(07 2022)
ISSN: 1468-2982 [Electronic] England |
PMID | 35302389
(Publication Type: Journal Article, Randomized Controlled Trial)
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Chemical References |
- Antibodies, Monoclonal, Humanized
- eptinezumab
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Topics |
- Antibodies, Monoclonal, Humanized
- Double-Blind Method
- Epilepsy
- Humans
- Migraine Disorders
(diagnosis)
- Migraine with Aura
- Self Report
- Treatment Outcome
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