Safety of galcanezumab in patients with episodic migraine: A randomized placebo-controlled dose-ranging Phase 2b study

What Was Tested

This randomized controlled trial paper looks at CGRP (Calcitonin Gene-Related Peptide) in the context of migraine.

Results Treatment-emergent adverse events (TEAEs) were primarily rated as mild to moderate.

Adverse events leading to discontinuation with galcanezumab treatment were abdominal pain, visual impairment, and upper limb fracture, each reported by one patient.

Who Took Part

The study group was 410 patients.

The age groups tagged for this paper are teenagers, young adults, adults, middle-aged adults and older adults, both men and women.

Methods Patients aged 18-65 years with episodic migraine were evaluated in this multicenter, double-blind, randomized study.

How the Study Was Run

The researchers set it up as a randomized, double-blind, placebo-controlled and multicenter study.

Because people in this CGRP (Calcitonin Gene-Related Peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Blinding on both sides kept the patients and researchers unaware of who received CGRP (Calcitonin Gene-Related Peptide).

The comparison arm used a placebo, so changes seen with CGRP (Calcitonin Gene-Related Peptide) could be set against what happens without it.

More than one site took part, so the patients came from several places.

What Was Measured

Topics PubMed links to this paper include Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Calcitonin Gene-Related Peptide and Migraine Disorders.

The authors tagged it with the keywords Galcanezumab, LY2951742, episodic migraine, phase 2b study and safety.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of CGRP (Calcitonin Gene-Related Peptide) in 410 patients in people with migraine.

With several hundred people or more, it is a fairly large study for this kind of research.

The publication is from 2018 (Cephalalgia : an international journal of headache), a journal based in England.

More context: the CGRP (Calcitonin Gene-Related Peptide) compound page, Migraine research.