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Monoclonal Antibodies

Galcanezumab 300 mg for Cluster Headache

Phase 3
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, week 3 through week 12
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial

Summary

The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic cluster headache.

Eligible Conditions
  • Cluster Headache

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 3 through week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 3 through week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Mean Change From Baseline in Weekly Cluster Headache Attack Frequency
Secondary study objectives
Percentage of Participants Developing Anti-Drug Antibodies (ADA) to Galcanezumab (LY2951742)
Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)
Percentage of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)
+5 more

Side effects data

From 2019 Phase 3 trial • 240 Patients • NCT02438826
15%
Nasopharyngitis
9%
Back pain
7%
Injection site pain
5%
Insomnia
5%
Sinusitis
5%
Arthralgia
4%
Diarrhoea
4%
Influenza like illness
4%
Upper respiratory tract infection
4%
Anxiety
4%
Hypertension
4%
Abdominal pain
4%
Influenza
4%
Constipation
3%
Bursitis
3%
Ligament sprain
3%
Non-cardiac chest pain
3%
Pyrexia
3%
Seasonal allergy
3%
Urinary tract infection
3%
Dizziness
3%
Fall
3%
Chest pain
3%
Fatigue
3%
Bronchitis
3%
Headache
3%
Ovarian cyst
3%
Injection site swelling
2%
Pain in extremity
2%
Cluster headache
2%
Palpitations
2%
Neck pain
2%
Depression
2%
Asthenia
2%
Injection site erythema
2%
Injection site pruritus
2%
Nausea
1%
Urinary tract infection bacterial
1%
Appendicitis
1%
Rectal abscess
1%
Arthrodesis
1%
Vertigo
1%
Tracheitis
1%
Weight increased
1%
Myalgia
1%
Nephrolithiasis
1%
Amaurosis
1%
Tinnitus
1%
Gastroenteritis
1%
Colon neoplasm
1%
Reversible cerebral vasoconstriction syndrome
1%
Visual impairment
1%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
GMB 300 mg/GMB 300 mg (Open-Label Treatment Phase)
GMB 300 mg/GMB 300 Mg-Post-Treatment Phase
Placebo (Double-Blind Treatment Phase)
Placebo (Post-Treatment Phase)
Galcanezumab 300 mg (Post-Treatment Phase)
Galcanezumab 300 mg (Double-Blind Treatment Phase)
Placebo/GMB 300 mg (Open-Label Treatment Phase)
Placebo/GMB 300 mg (Post-Treatment Phase)

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Galcanezumab 300 mgExperimental Treatment1 Intervention
Double-Blind Treatment Phase: Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months. Open-Label Treatment Phase: Participants received 300 mg galcanezumab by subcutaneous injections every 30 days, for up to a total of 12 administrations.
Group II: PlaceboPlacebo Group2 Interventions
Double-Blind Treatment Phase: Participants received placebo once a month by subcutaneous (SC) injection for 3 months. Open-Label Treatment Phase: Participants received 300 mg galcanezumab by subcutaneous injections every 30 days, for up to a total of 12 administrations.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Galcanezumab
FDA approved

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,660 Previous Clinical Trials
3,225,822 Total Patients Enrolled
2 Trials studying Cluster Headache
274 Patients Enrolled for Cluster Headache
Study DirectorEli Lilly and Company
1,381 Previous Clinical Trials
424,072 Total Patients Enrolled
2 Trials studying Cluster Headache
274 Patients Enrolled for Cluster Headache
~23 spots leftby Oct 2025
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