Tolerability and safety of galcanezumab in patients with chronic cluster headache with up to 15 months of galcanezumab treatment.

ABSTRACT:

Objective

The objective of the study was to assess the tolerability and safety of galcanezumab in patients with chronic cluster headache (CH) with up to 15 months of treatment.

Background

Chronic CH is a highly debilitating disease with a substantial and unmet medical need.

Methods

Patients were randomized to receive placebo or galcanezumab (300 mg) monthly for 12 weeks, followed by an optional 52-week open-label extension and 16-week posttreatment follow-up (washout). This is a secondary analysis and long-term follow-up of a previously conducted clinical trial. The safety analysis included patients who received galcanezumab at any time during the study. Outcomes included adverse events (AEs), discontinuations, laboratory values, vital signs, electrocardiograms (ECGs)

SUBMITTER: Lainez MJA 

PROVIDER: S-EPMC9299588 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature