← Human Trials & Peer-Reviewed Studies

Long-term safety and tolerability of eptinezumab in patients with chronic migraine: a 2-year, open-label, phase 3 trial

Plain-language guide to PMID 33740902 (2021): double-blind and open-label clinical trial, phase iii study of CGRP (Calcitonin Gene-Related Peptide), migraine.

Key Facts

PMID
33740902
Journal
BMC neurology
Year
2021
Study type
Clinical Trial, Phase III
Authors
Kudrow D et al. (7 authors)
DOI
10.1186/s12883-021-02123-w

What This Study Did, in Plain Language

What Was Tested

The paper reports a study of CGRP (Calcitonin Gene-Related Peptide) in the context of migraine, published as a clinical trial, phase iii.

Who Took Part

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

PREVAIL was an open-label, phase 3 trial comprising a 48-week treatment phase followed by a second 48-week treatment phase.

Patients were followed for 20 weeks after the final infusion (end-of-study visit at week 104).

How the Study Was Run

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

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

Nothing was hidden in this open-label CGRP (Calcitonin Gene-Related Peptide) study: the participants and staff both knew the treatment.

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

The timeline in the abstract includes 20 weeks.

What Was Measured

PubMed files the paper under topics including Administration, Intravenous, Antibodies, Monoclonal, Humanized, Calcitonin Gene-Related Peptide, Migraine Disorders, Nasopharyngitis, Patient Reported Outcome Measures and Quality of Life.

Author keywords: Chronic migraine, Effectiveness, Eptinezumab, Immunogenicity and Safety.

What This Means in Plain Language

The paper is a double-blind, open-label and placebo-controlled study of CGRP (Calcitonin Gene-Related Peptide) in people with migraine over 20 weeks.

The abstract goes on to report its results in about 6 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2021 (BMC 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.