Pharmacokinetics and safety of ubrogepant when coadministered with calcitonin gene-related peptide-targeted monoclonal antibody migraine preventives in participants with migraine: A randomized phase 1b drug-drug interaction study

What Was Tested

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

Who Took Part

The age groups tagged for this paper are adults and middle-aged adults, both men and women.

In this two-arm, multicenter, open-label, phase 1b trial, adults with migraine were randomized to arm 1 (ubrogepant ± erenumab) or arm 2 (ubrogepant ± galcanezumab).

In each study arm, serial blood samples were drawn on days 1 and 12 for measurement of plasma ubrogepant concentrations.

How the Study Was Run

The design is described as randomized, open-label and multicenter.

Because people in this CGRP (Calcitonin Gene-Related Peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Everyone knew when CGRP (Calcitonin Gene-Related Peptide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

More than one site took part, so the participants came from several places.

The PK profile of ubrogepant was characterized for administration before and 4 days after CGRP-targeted mAb injection.

Vital signs and laboratory parameters were monitored.

What Was Measured

PubMed files the paper under topics including Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Calcitonin Gene-Related Peptide, Drug Interactions, Migraine Disorders, Pyridines and Pyrroles.

The authors tagged it with the keywords CGRP, erenumab, galcanezumab, headache and ubrogepant.

What This Means in Plain Language

The paper is a randomized, open-label and multicenter study of CGRP (Calcitonin Gene-Related Peptide) in people with migraine.

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 (Headache), a journal based in United States.

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