Fremanezumab versus placebo for migraine prevention in patients with documented failure to up to four migraine preventive medication classes (FOCUS): a randomised, double-blind, placebo-controlled, phase 3b trial

What Was Tested

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

Who Took Part

PubMed indexes the participants as teenagers, young adults, adults, middle-aged adults and older adults, both men and women.

The primary outcome was mean change from baseline in the monthly average number of migraine days during the 12-week treatment period.

How the Study Was Run

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

The participants were allocated by chance, so the CGRP (Calcitonin Gene-Related Peptide) group and the comparison group should start out alike.

As a double-blind CGRP (Calcitonin Gene-Related Peptide) study, the assignments were hidden from both participants and investigators until the end.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

The randomised, double-blind, placebo-controlled, parallel-group, phase 3b FOCUS trial was done at 104 sites (including hospitals, medical centres, research institutes, and group practice clinics) across Belgium, the Czech Republic, Denmark, Finland, France, Germany, Italy, the Netherlands, Poland, Spain, Sweden, Switzerland, the UK, and the USA.

This trial is registered with ClinicalTrials.gov, number NCT03308968, and is now completed.

What Was Measured

The subject headings attached to it are Antibodies, Monoclonal, Calcitonin Gene-Related Peptide and Migraine Disorders.

What This Means in Plain Language

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

Its findings take up roughly 5 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2019 (Lancet (London, England)), a journal based in England.

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