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

A Phase 4 Single-Blind Study of Gastrointestinal Transit Time in Adult Patients With Migraine Before and After Initiation of a mAb CGRP Antagonist

Sponsors

Lead Sponsor: Eli Lilly and Company

Source Eli Lilly and Company
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 taking a monoclonal antibody (mAb) calcitonin gene-related peptide (CGRP) antagonist called galcanezumab or erenumab.

Overall Status Not yet recruiting
Start Date October 1, 2020
Completion Date February 8, 2021
Primary Completion Date February 8, 2021
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Change from Baseline in Colonic Transit Time (CTT), in Hours Baseline, Week 2
Secondary Outcome
Measure Time Frame
Change from Baseline in Whole Gut Transit Time (WGTT), in Hours Baseline, Week 2
Change from Baseline in Gastric Emptying Time (GET), in Hours Baseline, Week 2
Change from Baseline in Small Bowel Transit Time (SBTT), in Hours Baseline, Week 2
Change from Baseline in Combined Small and Large Bowel Transit Time (SLBTT), in Hours Baseline, Week 2
Change from Baseline in Motility Index Baseline, Week 2
Change from Baseline in Gastrointestinal (GI) Symptom Rating Scale (GSRS) Baseline, Week 4
Enrollment 60
Condition
Intervention

Intervention Type: Drug

Intervention Name: Galcanezumab

Description: Administered SC

Arm Group Label: Galcanezumab

Other Name: LY2951742

Intervention Type: Drug

Intervention Name: Erenumab

Description: Administered SC

Arm Group Label: Erenumab

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Study Director Eli Lilly and Company
Overall Contact

Last Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Phone: 1-317-615-4559

Email: [email protected]

Location
Facility: Contact: Investigator:
Pharmacology Research Institute | Newport Beach, California, 92660, United States 949-752-7910 Nader Oskooilar Principal Investigator
California Medical Clinic for Headache | Santa Monica, California, 90404, United States 310-315-1456 David B. Kudrow Principal Investigator
Dent Neurological Institute | Amherst, New York, 14226-0000, United States 716-558-5670 Laszlo L. Mechtler Principal Investigator
Rochester Clinical Research, Inc. | Rochester, New York, 14609, United States 585-288-0890 Matthew G Davis Principal Investigator
Location Countries

United States

Verification Date

September 15, 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Galcanezumab

Type: Experimental

Description: Galcanezumab administered subcutaneously (SC)

Label: Erenumab

Type: Active Comparator

Description: Erenumab administered SC

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Participant)

Source: ClinicalTrials.gov