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Calcitonin Gene-Related Peptide (CGRP) Antagonist

LY3451838 for Migraine

Phase 2
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
Must have a diagnosis of migraine with a history of migraine headaches of at least 1 year prior, and migraine onset prior to age 50.
Have completed at least 80% of required daily diary entries during the start of the study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 5 months
Awards & highlights

Study Summary

This trial is testing a new drug to see if it's safe and effective in treating migraines in people who haven't responded to other treatments.

Eligible Conditions
  • Migraine

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 5 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in the Number of Monthly Migraine Headache Days During 1-Month
Secondary outcome measures
Change From Baseline in the Number of Monthly Headache Days During 3-Month
Number of Participants With at Least One Serious Adverse Events (SAEs)
Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs)
+3 more

Side effects data

From 2022 Phase 2 trial • 38 Patients • NCT04498910
21%
Covid-19
21%
Urinary tract infection
11%
Pain in extremity
5%
Muscular weakness
5%
Upper respiratory tract infection
5%
Pollakiuria
5%
Insomnia
5%
Vomiting
5%
Confusional state
5%
Migraine
5%
Nasopharyngitis
5%
Fatigue
5%
Gastroenteritis
5%
Aphasia
5%
Constipation
5%
Dyspnoea
5%
Dysuria
5%
Ligament sprain
5%
B-cell lymphoma
5%
Contusion
5%
Aura
5%
Chills
5%
Decreased appetite
5%
Diarrhoea
5%
Lumbar puncture
5%
Pyrexia
5%
Abdominal pain
5%
Acute sinusitis
5%
Bronchitis
5%
Musculoskeletal pain
5%
Myalgia
5%
Rotator cuff syndrome
5%
Major depression
5%
Cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
1500 mg LY3451838

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: 1500 milligrams (mg) LY3451838Experimental Treatment1 Intervention
Participants received a single intravenous (IV) dose of 1500 mg LY3451838.
Group II: PlaceboPlacebo Group1 Intervention
Participants received a single IV dose of placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3451838
2020
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,612 Previous Clinical Trials
3,200,869 Total Patients Enrolled
26 Trials studying Migraine
10,490 Patients Enrolled for Migraine
Study DirectorEli Lilly and Company
1,343 Previous Clinical Trials
405,192 Total Patients Enrolled
20 Trials studying Migraine
7,617 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.
Recent research and studies
clinicaltrials.govStudy
A Study of LY3451838 in Participants With Migraine
2020. "A Study of LY3451838 in Participants With Migraine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04498910.
~9 spots leftby Apr 2025
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