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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 5 months
Awards & highlights

Summary

This trial is testing a new medication called LY3451838 to see if it can help people whose migraines haven't improved with other treatments.

Eligible Conditions
  • Migraine

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in the Number of Monthly Migraine Headache Days During 1-Month
Secondary study objectives
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%
Urinary tract infection
21%
Covid-19
11%
Pain in extremity
5%
Aphasia
5%
Abdominal pain
5%
Cough
5%
Myalgia
5%
Chills
5%
Ligament sprain
5%
Diarrhoea
5%
Fatigue
5%
Upper respiratory tract infection
5%
Decreased appetite
5%
Muscular weakness
5%
Rotator cuff syndrome
5%
Dysuria
5%
Acute sinusitis
5%
Nasopharyngitis
5%
Gastroenteritis
5%
Musculoskeletal pain
5%
Major depression
5%
Insomnia
5%
Pollakiuria
5%
Constipation
5%
Dyspnoea
5%
B-cell lymphoma
5%
Bronchitis
5%
Vomiting
5%
Pyrexia
5%
Contusion
5%
Lumbar puncture
5%
Aura
5%
Migraine
5%
Confusional state
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
2,651 Previous Clinical Trials
3,224,429 Total Patients Enrolled
26 Trials studying Migraine
10,483 Patients Enrolled for Migraine
Study DirectorEli Lilly and Company
1,369 Previous Clinical Trials
421,356 Total Patients Enrolled
20 Trials studying Migraine
7,610 Patients Enrolled for Migraine
~8 spots leftby Oct 2025