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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 weeks 1 to 4, 13 to 16, 25 to 28, and 37 to 40
Awards & highlights

CHRONICLE Trial Summary

This trial will help researchers learn more about the long-term effects of eptinezumab on people with chronic cluster headaches.

Eligible Conditions
  • Chronic Cluster Headache

CHRONICLE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 1 to 4, 13 to 16, 25 to 28, and 37 to 40
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1 to 4, 13 to 16, 25 to 28, and 37 to 40 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Adverse Events
Secondary outcome measures
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, Averaged Over the First 4 Weeks After Each Infusion
+14 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

CHRONICLE 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
~2040

Find a Location

Who is running the clinical trial?

H. Lundbeck A/SLead Sponsor
326 Previous Clinical Trials
77,552 Total Patients Enrolled
1 Trials studying Cluster Headache
232 Patients Enrolled for Cluster Headache
Email contact via H. Lundbeck A/SStudy DirectorH. Lundbeck A/S
188 Previous Clinical Trials
58,209 Total Patients Enrolled
1 Trials studying Cluster Headache
232 Patients Enrolled for Cluster Headache
~36 spots leftby Jun 2025
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