Long-term safety and tolerability of erenumab: Three-plus year results from a five-year open-label extension study in episodic migraine.

ABSTRACT:

Background

Previously published three-month placebo-controlled and one-year open-label clinical trial data have provided information on the efficacy and safety of erenumab.

Methods

Interim analysis was undertaken from an ongoing five-year open-label treatment phase after all patients completed three years in the open-label treatment phase or discontinued the study. Adult patients with episodic migraine enrolled in the open-label treatment phase initially received 70 mg erenumab monthly. A protocol amendment increased the dosage to 140 mg monthly to assess long-term safety of the higher dose. Safety and tolerability were assessed by monitoring adverse events, electrocardiograms, laboratory assessments, and vital signs.

Results

Of 383 patients enrolled in the open-label

SUBMITTER: Ashina M 

PROVIDER: S-EPMC6779015 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature