Completed

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

I5Q-MC-CGBC - ClinicalTrials.gov - NCT04294147

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.
How long will I be in the trial?
The study will last about 4 weeks and may include up to 5 visits.
Email
Completed

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

I5Q-MC-CGBC - ClinicalTrials.gov - NCT04294147

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.
How long will I be in the trial?
The study will last about 4 weeks and may include up to 5 visits.
Email

Key Requirements

Age :

18-55

Sex:

All

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18-55

Sex

All

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

Trial Summary

Conditions the trial is for

Migraine

What the trial is testing?

Galcanezumab, Erenumab

Could I receive a Placebo?

no

Enrollment Goal

60

Trial Dates

October 2020 - March 2021

Trial Phase

4

Enter your postal code to find the nearest site

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18-55

Sex

All

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

Trial Summary

Conditions the trial is for

Migraine

What the trial is testing?

Galcanezumab, Erenumab

Could I receive a Placebo?

no

Enrollment Goal

60

Trial Dates

October 2020 - March 2021

Trial Phase

4

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Trial Locations

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Migraine Resources

Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?