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Impact of age and sex on the efficacy of fremanezumab in patients with difficult-to-treat migraine: results of the randomized, placebo-controlled, phase 3b FOCUS study
Plain-language guide to PMID 34922436 (2021): double-blind randomized controlled trial study of CGRP (Calcitonin Gene-Related Peptide), migraine.
Key Facts
- PMID
- 34922436
- Journal
- The journal of headache and pain
- Year
- 2021
- Study type
- Randomized Controlled Trial
- Authors
- MaassenVanDenBrink A et al. (8 authors)
- DOI
- 10.1186/s10194-021-01336-1
What This Study Did, in Plain Language
What Was Tested
This randomized controlled trial paper looks at CGRP (Calcitonin Gene-Related Peptide) in the context of migraine.
Migraine prevalence is age and sex dependent, predominating in women in early and middle adulthood; however, migraine also represents a substantial burden for men and adults of all ages.
ClinicalTrials.gov Identifier NCT03308968 (FOCUS), registered October 13, 2017.
Who Took Part
The age groups tagged for this paper are teenagers, young adults, adults and middle-aged adults, both men and women.
In the FOCUS study, eligible participants were randomized (1:1:1) to 12 weeks of double-blind treatment with quarterly fremanezumab, monthly fremanezumab, or matched monthly placebo.
How the Study Was Run
The design is described as randomized, double-blind and placebo-controlled.
The participants were allocated by chance, so the CGRP (Calcitonin Gene-Related Peptide) group and the comparison group should start out alike.
Neither the participants nor the staff measuring them knew who was on CGRP (Calcitonin Gene-Related Peptide), so expectations could not easily colour the readings.
The comparison arm used a placebo, so changes seen with CGRP (Calcitonin Gene-Related Peptide) could be set against what happens without it.
What Was Measured
The subject headings attached to it are Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Calcitonin Gene-Related Peptide and Migraine Disorders.
Author keywords: Age, Fremanezumab and Sex.
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.
Results are reported in around 4 sentences of the abstract; we leave them to the paper itself rather than summarise them.
The publication is from 2021 (The journal of headache and pain), a journal based in England.
More context: the CGRP (Calcitonin Gene-Related Peptide) compound page, Migraine research.
Our Notes on the Compound
CGRP (Calcitonin Gene-Related Peptide): A 37-amino-acid neuropeptide that widens blood vessels and is involved in migraine; given in research provocation studies.
Related Pages
Source: PubMed record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.