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

Lilly

Status and phase: Completed; Phase 4

Conditions: Migraine; Episodic Migraine

Treatments: Drug: Placebo; Drug: Galcanezumab; Drug: Rimegepant

Study type: Interventional

Funder types: Industry

Identifiers

NCT05127486

I5Q-MC-CGBD (Other Identifier)

18256

Details and patient eligibility

About

The purpose of this study is to assess whether galcanezumab is superior to rimegepant in the prevention of migraine in participants with episodic migraine. The study duration will be approximately 6 months.

Enrollment: 580 patients

Sex: All

Ages: 18 to 75 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)

Exclusion criteria

• Have a known hypersensitivity to rimegepant or galcanezumab, and their excipients, monoclonal antibodies or other therapeutic proteins
• 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.
• Evidence of significant psychiatric disease by medical history, such as schizophrenia, personality disorders, or other serious mood or anxiety disorders.
• Women who are pregnant or nursing
• Current use or prior exposure to any calcitonin gene related peptide (CGRP) antagonist (small molecule or antibody) for any indication, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antagonist (small molecule or antibody)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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580 participants in 2 patient groups

Galcanezumab

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Galcanezumab

Drug: Placebo

Rimegepant

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: Rimegepant

Drug: Placebo