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Monoclonal Antibodies
A Study Of Galcanezumab In Participants With Episodic 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 month 1 through month 6
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Summary
The main purpose of this study is to evaluate the efficacy and safety of the study drug known as Galcanezumab in participants with episodic cluster headaches.
Eligible Conditions
- Cluster headache
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 1 through month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 1 through month 6
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks
Percentage of Participants Developing Anti-Drug Antibodies (ADA) to Galcanezumab
Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)
+5 moreSide effects data
From 2021 Phase 4 trial • 65 Patients • NCT0429414716%
Constipation
6%
Covid-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
140 mg Erenumab SC
240 mg Galcanezumab SC
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 300mgExperimental Treatment1 Intervention
Galcanezumab 300mg administered subcutaneously (SC) every 30 days during an 8 week treatment period.
Group II: PlaceboPlacebo Group1 Intervention
Placebo administered SC every 30 days during an 8 week treatment period.
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
2,680 Previous Clinical Trials
3,466,275 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,391 Previous Clinical Trials
428,732 Total Patients Enrolled