A phase IV clinical trial of gastrointestinal motility in adult patients with migraine before and after initiation of a calcitonin gene-related peptide ligand (galcanezumab) or receptor (erenumab) antagonist

What Was Tested

Researchers studied CGRP (Calcitonin Gene-Related Peptide) in the context of migraine in this randomized controlled trial publication.

Different frequencies of constipation have been observed between CGRP mAbs that target the ligand (galcanezumab [GMB]) or receptor (erenumab [ERE]).

Who Took Part

The age groups tagged for this paper are adults.

The primary endpoint was change from baseline in colonic transit time (CTT) within each treatment group.

Other measures included GI Symptom Rating Scale (GSRS), Bristol Stool Form Scale (BSFS), and spontaneous bowel movement (SBM) evaluation.

How the Study Was Run

The researchers set it up as a randomized, double-blind and single-blind study.

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

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

In this single-blind CGRP (Calcitonin Gene-Related Peptide) study one party knew the assignments and the other did not.

GI whole and regional transit times were assessed using a wireless motility capsule 1 week before and 2 weeks after mAb administration.

AEs were monitored throughout the study.

What Was Measured

Topics PubMed links to this paper include Calcitonin Gene-Related Peptide, Constipation, Gastrointestinal Motility, Ligands, Migraine Disorders, Antibodies, Monoclonal, Humanized and Calcitonin Gene-Related Peptide Receptor Antagonists.

Author keywords: colonic transit time and monoclonal antibodies.

What This Means in Plain Language

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

The abstract goes on to report its results in about 8 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2022 (Headache), a journal based in United States.

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