Galcanezumab for Migraine

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Migraine+2 More
Galcanezumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the effectiveness of two drugs for preventing migraines. It will last for six months.

Eligible Conditions
  • Migraine
  • Episodic Migraine

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: Month 1 through Month 3

Baseline, 3 Months
Change from Baseline in Emotional Function (EF) Domain Score of Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1)
Change from Baseline in MIDAS (Migraine Disability Assessment) Total Score
Change from Baseline in Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) Total Score
Change from baseline in Role Function-Preventive (RF-P) Domain Score of Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1)
Mean Change from Baseline in the Number of Monthly Migraine Headache Days
Mean Change from Baseline in the Role Function-Restrictive (RF-R) Domain Score of the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1)
Month 3
Overall Mean Change from Baseline in the Number of Monthly Migraine Headache Days
Overall Mean Change from Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache
Month 3
Mean Monthly Percentage of Participants with a 100% Response Rate
Mean Monthly Percentage of Participants with a 50% Response Rate
Mean Monthly Percentage of Participants with a 75% Response Rate

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

240 mg Galcanezumab SC
6%Abdominal pain upper
3%Constipation
This histogram enumerates side effects from a completed 2021 Phase 4 trial (NCT04294147) in the 240 mg Galcanezumab SC ARM group. Side effects include: Abdominal pain upper with 6%, Constipation with 3%.

Trial Design

2 Treatment Groups

Rimegepant
1 of 2
Galcanezumab
1 of 2
Active Control
Experimental Treatment

575 Total Participants · 2 Treatment Groups

Primary Treatment: Galcanezumab · Has Placebo Group · Phase 4

GalcanezumabExperimental Group · 2 Interventions: Placebo, Galcanezumab · Intervention Types: Drug, Drug
RimegepantActiveComparator Group · 2 Interventions: Placebo, Rimegepant · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Galcanezumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: month 1 through month 3

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,453 Previous Clinical Trials
3,120,150 Total Patients Enrolled
25 Trials studying Migraine
9,993 Patients Enrolled for Migraine
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 DirectorEli Lilly and Company
1,250 Previous Clinical Trials
366,978 Total Patients Enrolled
20 Trials studying Migraine
7,150 Patients Enrolled for Migraine

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 2nd, 2021

Last Reviewed: October 17th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
North Carolina33.3%
Texas33.3%
Delaware33.3%
How old are they?
18 - 65100.0%
What site did they apply to?
FutureSearch Trials of Neurology50.0%
Alliance for Multispecialty Research, LLC - AMR Norfolk50.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%