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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 month 1 through month 3
Awards & highlights

CHALLENGE-MIG Trial Summary

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

Eligible Conditions
  • Migraine with Aura
  • Migraine

CHALLENGE-MIG Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 1 through month 3
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 1 through month 3 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Monthly Percentage of Participants with a 50% Response Rate
Secondary outcome measures
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
+7 more

Side effects data

From 2021 Phase 4 trial • 65 Patients • NCT04294147
16%
Constipation
6%
Covid-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
140 mg Erenumab SC
240 mg Galcanezumab SC

CHALLENGE-MIG Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: GalcanezumabExperimental Treatment2 Interventions
Galcanezumab administered subcutaneously (SC). Placebo for rimegepant will be used for blinding.
Group II: RimegepantActive Control2 Interventions
Rimegepant administered oral disintegrating tablets (ODT). Placebo for galcanezumab will be used for blinding.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Galcanezumab
2015
Completed Phase 4
~6760
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,617 Previous Clinical Trials
3,200,613 Total Patients Enrolled
26 Trials studying Migraine
9,941 Patients Enrolled for Migraine
Study DirectorEli Lilly and Company
1,346 Previous Clinical Trials
404,807 Total Patients Enrolled
20 Trials studying Migraine
7,068 Patients Enrolled for Migraine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this a fresh clinical trial?

"Since 2018, Eli Lilly and Company have sponsored a string of clinical trials focusing on Galcanezumab. The first trial in 2018 involved 325 patients which ultimately led to its Phase 3 drug approval. In the present day there are 11 ongoing investigations spanning 296 cities across 16 nations."

Answered by AI

Are any Canadian health centers conducting this clinical experiment?

"Recruitment for this trial is currently occurring at 96 different sites. These locations are primarily based in Hazelwood, Cleveland and Memphis, though there are plenty of other options close by to minimise travelling demands upon potential participants."

Answered by AI

What health conditions have been alleviated through Galcanezumab treatments?

"Galcanezumab is an effective form of preventative therapy for migraine headaches, as well as their associated aura and other symptoms."

Answered by AI

Has Galcanezumab been tested before in a scientific experiment?

"Currently, 11 clinical trials are ongoing for Galcanezumab of which 5 are in Phase 3. The majority of studies take place in Durham, North carolina but there exists a total 732 research sites across the United States that offer this treatment to participants."

Answered by AI

To what extent does Galcanezumab pose a threat to individuals?

"Galcanezumab was given a ranking of 3, as it is already an approved treatment and this study constitutes its fourth phase."

Answered by AI

Is this research still recruiting participants?

"The information available on clinicaltrials.gov implies that patient recruitment for this medical trial is ongoing, given the initial posting date of December 6th 2021 and recent update of November 22nd 2022."

Answered by AI

Who is eligible to join this clinical investigation?

"This clinical trial seeks to recruit 575 individuals suffering from migraine, ranging between 18 and 75 years of age. In order for them to meet the criteria set forth by this study they must have been diagnosed with a migrane in accordance to International Headache Society's ICHD-3 2018 guidelines."

Answered by AI

What is the cap on participant recruitment for this research project?

"To make this medical trial a success, 575 participants who meet the pre-determined criteria need to join. Among other locations, Healthcare Research Network - Hazelwood in Missouri and Rapid Medical Research in Ohio are available sites for potential study members."

Answered by AI

Is this medical trial open to participants of over forty years?

"Per the requirements of this clinical trial, participants must be aged 18 or older and not exceed 75 years old."

Answered by AI

Who else is applying?

What state do they live in?
Nevada
Texas
North Carolina
Other
How old are they?
18 - 65
What site did they apply to?
North Carolina Clinical Research
Alliance for Multispecialty Research, LLC - AMR Norfolk
Other
FutureSearch Trials of Neurology
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
3+
0

Why did patients apply to this trial?

I want relief. I have bad migraine headaches. suffer from chronic migraines. on propranolol but looking for a more preventative measure.
PatientReceived 2+ prior treatments
I have chronic migraines and nothing has worked well to treat them. I seem to get some relief from Emgality and Botox shots, but I do not respond to abortives.
PatientReceived 1 prior treatment
I've tried several medications and they just don't work. I am looking for something that can stop the pain, the nausea, vomiting and everything else that I go through.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine
2021. "A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05127486.
~176 spots leftby Apr 2025
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