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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
325 Previous Clinical Trials
77,452 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Will patients who are over the age of 35 still be able to participate in this research?

"People aged 18 to 75 are eligible for this trial, with 22 other trials available for minors and 99 for seniors."

Answered by AI

Can you please list any other occasions where Eptinezumab has been tested in a clinical setting?

"There are 7 ongoing studies that are researching eptinezumab. Of those, 6 have reached Phase 3 clinical trials. While the majority of the eptinezumab studies are taking place in Novosibirsk, there are also active trials in England and 287 other locations."

Answered by AI

Are investigators actively enrolling new participants for this research?

"Unfortunately, the most recent update on clinicaltrials.gov shows that this particular study is not presently looking for any more patients. This trial was initially posted on September 17th, 2021 and was last updated on August 4th, 2022. However, there are 149 other trials that are currently looking for patients."

Answered by AI

To how many different hospitals has this study been outsourced?

"This study's primary locations are Cleveland Clinic - Neurological Institute in Cleveland, Ohio, Thomas Jefferson University Hospital - Center City Campus in Philadelphia, Pennsylvania, and Michigan Headache and Neurological Institute in Ann Arbor, Michigan. There are also 5 other satellite locations."

Answered by AI

Are there any fatal side effects associated with Eptinezumab?

"Eptinezumab's safety is based on efficacy data from Phase 3 trials and supporting safety data, leading to a score of 3."

Answered by AI

What other research is there in this area?

"Eptinezumab has been researched since 2020 by H. Lundbeck A/S. The first study, which only involved 32 people, was conducted in 2020. After the initial study, Eptinezumab received Phase 1 drug approval and has since been trialed 7 times in 25 countries across 128 cities."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A 1-year Trial to Inform About Long-term Exposure to Eptinezumab in Participants With Chronic Cluster Headache (cCH)
2021. "A 1-year Trial to Inform About Long-term Exposure to Eptinezumab in Participants With Chronic Cluster Headache (cCH)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05064397.
~37 spots leftby Apr 2025
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