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Monoclonal Antibodies

Eptinezumab for Cluster Headache (CHRONICLE Trial)

Phase 3
Waitlist Available
Research Sponsored by H. Lundbeck A/S
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 0), months 1-12
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial aims to study the long-term safety and tolerability of eptinezumab in people who have chronic cluster headaches. Eptinezumab is a medication that helps prevent headaches by blocking certain pain signals in the brain. Participants will be monitored for several months with regular check-ins, and they will keep a headache diary at home.

Eligible Conditions
  • Cluster Headache

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 0), months 1-12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 0), months 1-12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Treatment-emergent Adverse Events (AEs)
Secondary study objectives
Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used
+15 more

Side effects data

From 2020 Phase 3 trial • 485 Patients • NCT04152083
2%
Hypersensitivity
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Eptinezumab

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: EptinezumabExperimental Treatment1 Intervention
Participants will receive 4 intravenous (IV) infusions with eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eptinezumab
2021
Completed Phase 3
~2200

Find a Location

Who is running the clinical trial?

H. Lundbeck A/SLead Sponsor
329 Previous Clinical Trials
77,578 Total Patients Enrolled
1 Trials studying Cluster Headache
231 Patients Enrolled for Cluster Headache
Email contact via H. Lundbeck A/SStudy DirectorH. Lundbeck A/S
189 Previous Clinical Trials
58,198 Total Patients Enrolled
1 Trials studying Cluster Headache
231 Patients Enrolled for Cluster Headache
~31 spots leftby Nov 2025
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