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Safety, tolerability, and efficacy of orally administered atogepant for the prevention of episodic migraine in adults: a double-blind, randomised phase 2b/3 trial
Plain-language guide to PMID 32822633 (2020): double-blind randomized controlled trial study of CGRP (Calcitonin Gene-Related Peptide), migraine.
Key Facts
- PMID
- 32822633
- Journal
- The Lancet. Neurology
- Year
- 2020
- Study type
- Randomized Controlled Trial
- Authors
- Goadsby PJ et al. (7 authors)
- DOI
- 10.1016/S1474-4422(20)30234-9
What This Study Did, in Plain Language
What Was Tested
Researchers studied CGRP (Calcitonin Gene-Related Peptide) in the context of migraine in this randomized controlled trial publication.
The main outcomes to assess safety and tolerability were adverse event recordings.
Why It Was Studied
Atogepant is an orally administered, small-molecule, calcitonin gene-related peptide (CGRP) receptor antagonist under investigation for treatment of migraine.
Who Took Part
PubMed indexes the participants as adults and middle-aged adults, both men and women.
The primary outcome was change from baseline in monthly migraine days across 12 weeks of treatment using a modified intention-to-treat approach.
How the Study Was Run
In design terms this was a randomized, double-blind and placebo-controlled study.
Random assignment meant chance, not the researchers, decided who got CGRP (Calcitonin Gene-Related Peptide) and who got the comparison, which limits bias.
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.
Some participants received a placebo instead of CGRP (Calcitonin Gene-Related Peptide), giving a reference point.
The study was done in 78 academic and private practice settings in the USA.
The trial is registered with ClinicalTrials.gov, NCT02848326 and is completed.
What Was Measured
PubMed files the paper under topics including Calcitonin Gene-Related Peptide, Drugs, Investigational 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 11 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.
The publication is from 2020 (The Lancet. Neurology), 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.