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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-06

Study Completion Date

2021-03-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Galcanezumab

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

Group Type EXPERIMENTAL

Galcanezumab

Intervention Type DRUG

Administered SC

Erenumab

Participants received a single SC dose of 140 mg Erenumab.

Group Type ACTIVE_COMPARATOR

Erenumab

Intervention Type DRUG

Administered SC

Interventions

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Galcanezumab

Administered SC

Intervention Type DRUG

Erenumab

Administered SC

Intervention Type DRUG

Other Intervention Names

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LY2951742

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No