Status:
COMPLETED
A Study of Gastrointestinal Emptying Time in Adult Participants With Migraine Before and After Start of a mAb CGRP Antagonist
Lead Sponsor:
Eli Lilly and Company
Conditions:
Migraine
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief Summary
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 ta...
Eligibility Criteria
Inclusion
- Have a diagnosis of migraine, with or without aura, as determined by the study investigator and in consideration of International Headache Society International Classification of Headache Disorders - 3rd edition guidelines (ICHD-3 2018)
- Have a frequency of less than 15 monthly headache days of which up to 14 can be migraine headache days.
- 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 have received onabotulinumtoxinA for a minimum of 2 cycles prior to screening
Exclusion
- Participants with a history of gastric bezoars, swallowing disorders, severe dysphagia to food or pills, suspected or known strictures, fistulas, or physiological/mechanical GI obstruction
- History of any abdominal surgery within the past 3 months or GI surgery with the exception of cholecystectomy, appendectomy, or Nissen fundoplication
- History of irritable bowel syndrome (IBS), chronic constipation, Crohn's disease, celiac disease, ulcerative colitis, or diverticulitis
- Participants with type 1 or type 2 diabetes
- Participants with cardiac pacemakers or other implanted or portable electromechanical device
- Participants with a body mass index of ≥40 kilograms per square meter (kg/m²)
- Women who are pregnant or nursing
- Participants currently on mAb CGRP antagonists or have received a mAb CGRP antagonist within the past 6 months prior to visit 1
- Participants who have received an oral CGRP antagonist (gepant) in the last 14 days prior to Visit 1
Key Trial Info
Start Date :
October 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2021
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04294147
Start Date
October 6 2020
End Date
March 5 2021
Last Update
March 22 2022
Active Locations (3)
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1
Clinical Research Institute LLC
Los Angeles, California, United States, 90048
2
Pharmacology Research Institute
Newport Beach, California, United States, 92660
3
CMR of Greater New Haven
Waterbury, Connecticut, United States, 06708