A Study of Gastrointestinal Emptying Time in Adult Participants With Migraine Before and After Start of a mAb CGRP Antagonist

I5Q-MC-CGBC -

The purpose of this study is to measure the gastrointestinal emptying time using the wireless motility capsule (WMC) technology (FDA approved SmartPill™) in adult participants with migraine who are taking a calcitonin gene-related peptide (CGRP) antagonist called Galcanezumab or Erenumab.

Trial Summary

Age Range
18 - 55 years
Conditions the trial is for
Migraines
What the trial is testing?
Erenumab, Galcanezumab
Could I receive a Placebo?
No
Enrollment Goal
65
Trial Dates
Oct 6, 2020 - Mar 5, 2021
How long will I be in the trial?
The study will last about 4 weeks and may include up to 5 visits.
Trial Phase
IV

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • Participants must have a diagnosis of migraine, with or without aura, or chronic migraine, as determined by the study investigator and in consideration of International Headache Society International Classification of Headache Disorders 3rd edition guidelines (ICHD-3 2018)

  • Participants can be on no more than 1 other migraine preventive treatment (except for tricyclic antidepressants and verapamil which are not allowed) as long as: that participant has had a stable dose of the oral migraine preventive treatment for a minimum of 2 months or participants with chronic migraine have received onabotulinumtoxinA for a minimum of 2 cycles prior to screening

Participants Must Not:

  • Participants must not have a history of gastric bezoars, swallowing disorders, severe dysphagia to food or pills, suspected or known strictures, fistulas, or physiological/mechanical GI obstruction

  • Participants must not have a history of any abdominal surgery within the past 3 months or GI surgery with the exception of cholecystectomy, appendectomy, or Nissen fundoplication

  • Participants must not have a history of irritable bowel syndrome (IBS), chronic constipation, Crohn's disease, celiac disease, ulcerative colitis, or diverticulitis

  • Participants must not have type 1 or type 2 diabetes

  • Participants must not have cardiac pacemakers or other implanted or portable electromechanical device

  • Participants must not have a body mass index of 50 kilograms per square meter (kg/m²)

  • Participants must not be women who are pregnant or nursing

  • Participants must not be currently on CGRP antagonists or have taken CGRP antagonist within the past 6 months

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