A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine
(CHALLENGE-MIG Trial)

Recruiting in Palo Alto (17 mi)

+100 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Eli Lilly and Company

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is comparing two medications, galcanezumab and rimegepant, to see which is better at preventing migraines in people who have them occasionally. Both medications work by blocking a protein that triggers migraine pain. The study will last several months. Galcanezumab has been shown to reduce migraine headache days in previous studies.

Research Team

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)

Principal Investigator

Eli Lilly and Company

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)

Exclusion Criteria

Have acute cardiovascular events and/or serious cardiovascular risk, or have had myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft, or stroke within 6 months of screening, or have planned cardiovascular surgery or percutaneous coronary angioplasty.

You have taken any medication that blocks calcitonin gene related peptide (CGRP) in the past or are currently taking it.

Women who are pregnant or nursing

See 2 more

Treatment Details

Interventions

Galcanezumab (Monoclonal Antibodies)

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: GalcanezumabExperimental Treatment2 Interventions

Participants received a loading dose of 2 injections of 120 milligrams (mg) galcanezumab subcutaneously (SC) in the first month followed by 120 mg monthly for remaining 2 months. 1 placebo oral disintegrating tablet (ODT) every other day for 3 months was given to preserve blinding.

Group II: RimegepantActive Control2 Interventions

Participants received 75 mg Rimegepant oral disintegrating tablet (ODT) every other day for 3 months. 2 placebo SC injections loading dose, then 1 placebo SC injection monthly for remaining 2 months was given to preserve blinding.