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

Lilly

Status and phase: Completed; Phase 4

Conditions: Migraine

Treatments: Drug: Galcanezumab; Drug: Erenumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04294147

17590

I5Q-MC-CGBC (Other Identifier)

Details and patient eligibility

About

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 monoclonal antibody (mAb) calcitonin gene-related peptide (CGRP) antagonist called galcanezumab or erenumab.

Enrollment: 65 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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65 participants in 2 patient groups

Galcanezumab

Experimental group

Description:

Participants received a single subcutaneous (SC) dose of 240 milligram (mg) Galcanezumab.

Treatment:

Drug: Galcanezumab

Erenumab

Active Comparator group

Description:

Participants received a single SC dose of 140 mg Erenumab.

Treatment:

Drug: Erenumab