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Eptinezumab For The Prevention Of Chronic Migraine: Efficacy And Safety Through 24 Weeks Of Treatment In The Phase 3 Promise-2 (Prevention Of Migraine Via Intravenous Ald403 Safety And Efficacy-2) Study., Stephen Silberstein, Merle Diamond, Nada A. Hindiyeh, David M. Biondi, Roger Cady, Joe Hirman, Brent Allan, Susan Pederson, Barbara Schaeffler, Jeff Smith
Eptinezumab For The Prevention Of Chronic Migraine: Efficacy And Safety Through 24 Weeks Of Treatment In The Phase 3 Promise-2 (Prevention Of Migraine Via Intravenous Ald403 Safety And Efficacy-2) Study., Stephen Silberstein, Merle Diamond, Nada A. Hindiyeh, David M. Biondi, Roger Cady, Joe Hirman, Brent Allan, Susan Pederson, Barbara Schaeffler, Jeff Smith
Department of Neurology Faculty Papers
BACKGROUND: PROMISE-2 was a phase 3, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of repeat intravenous (IV) doses of the calcitonin gene-related peptide-targeted monoclonal antibody eptinezumab (ALD403) for migraine prevention in adults with chronic migraine. This report describes the results of PROMISE-2 through 24 weeks of treatment.
METHODS: Patients received up to two 30-min IV administrations of eptinezumab 100 mg, 300 mg, or placebo separated by 12 weeks. Patients recorded migraine and headache endpoints in a daily eDiary. Additional assessments, including patient-reported outcomes, were performed at regularly scheduled clinic visits throughout the 32-week study period (screening, day …
The Impact Of Fremanezumab On Medication Overuse In Patients With Chronic Migraine: Subgroup Analysis Of The Halo Cm Study., Stephen D. Silberstein, Joshua M. Cohen, Michael J. Seminerio, Ronghua Yang, Sait Ashina, Zaza Katsarava
The Impact Of Fremanezumab On Medication Overuse In Patients With Chronic Migraine: Subgroup Analysis Of The Halo Cm Study., Stephen D. Silberstein, Joshua M. Cohen, Michael J. Seminerio, Ronghua Yang, Sait Ashina, Zaza Katsarava
Department of Neurology Faculty Papers
BACKGROUND: We evaluated the efficacy of fremanezumab, a fully humanized monoclonal antibody that selectively targets calcitonin gene-related peptide, in patients with chronic migraine (CM) with and without medication overuse (MO).
METHODS: In a 12-week, phase 3 trial, patients with CM were randomized to fremanezumab quarterly (675 mg/placebo/placebo), monthly (675 mg/225 mg/225 mg), or placebo. Post hoc analyses assessed the impact of fremanezumab in patients with and without MO (monthly use of acute headache medication ≥15 days, migraine-specific acute medication ≥10 days, or combination medication ≥10 days) on efficacy outcomes, including headache days of at least moderate severity (HDs), and six-item …