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Monoclonal Antibodies

Galcanezumab for Migraine (CHALLENGE-MIG Trial)

Phase 4

Waitlist Available

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, month 1 through month 3

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

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.

Eligible Conditions

Migraine

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, month 1 through month 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, month 1 through month 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 1 through month 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants With 50% Response Rate Across the 3-month Treatment Period.

Secondary study objectives

Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) at Month 3

Mean Change From Baseline in the Number of Monthly Migraine Headache Days at Month 1

Mean Change From Baseline in the Number of Monthly Migraine Headache Days at Month 2

+6 more

Side effects data

From 2021 Phase 4 trial • 65 Patients • NCT04294147

16%

Constipation

Covid-19

100%

80%

60%

40%

20%

Study treatment Arm

140 mg Erenumab SC

240 mg Galcanezumab SC

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Galcanezumab

2015

Completed Phase 4

~6750

Placebo

1995

Completed Phase 3

~2670