NCT05064397

A 1-year Trial to Inform About Long-term Exposure to Eptinezumab in Participants With Chronic Cluster Headache (cCH)

Interventional, Open-label, Fixed-dose Multiple Administration Study to Evaluate Long-term Treatment With Eptinezumab in Patients With Chronic Cluster Headache

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The main goal of this trial is to inform about long-term safety and tolerability of eptinezumab in participants with chronic cluster headache.

Detailed description

The participants who take part in this trial will be asked to stay in the trial for about a year. The participants will be asked to visit the trial site 7 times during the trial. In between trial site visits, they will have scheduled phone calls with the trial site staff. They will also be asked to keep track of their cluster headaches at home with a headache diary.

Conditions

• Chronic Cluster Headache

Interventions

Type	Name	Description
DRUG	Eptinezumab	Eptinezumab will be administered per schedule specified in the arm description.

Timeline

• Start date: 2021-09-17
• Primary completion: 2023-06-29
• Completion: 2023-06-29
• First posted: 2021-10-01
• Last updated: 2024-08-06
• Results posted: 2024-08-06

Locations

31 sites across 9 countries: United States, Denmark, Finland, France, Germany, Italy, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study