NCT04688775

Eptinezumab in Participants With Episodic Cluster Headache

Interventional, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Delayed-Start Study to Evaluate the Efficacy and Safety of Eptinezumab in Patients With Episodic Cluster Headache

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 231 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of eptinezumab in participants with episodic Cluster Headache (eCH)

Detailed description

Eligible participants will be randomly assigned to receive treatment, in a blinded manner, two infusions of either eptinezumab or placebo in a cross-over manner during the Placebo-controlled Period and Active Treatment Period of the study. The total duration of the study after randomization is 24 weeks, including a safety follow-up period of 8 weeks.

Conditions

• Cluster Headache, Episodic

Interventions

Type	Name	Description
DRUG	Eptinezumab	Eptinezumab - concentrate for solution for infusion, intravenously
DRUG	Placebo	Placebo - 100 milliliters (mL) of 0.9% normal saline, intravenously

Timeline

• Start date: 2020-12-23
• Primary completion: 2023-06-14
• Completion: 2023-10-05
• First posted: 2020-12-30
• Last updated: 2024-08-09
• Results posted: 2024-08-09

Locations

120 sites across 19 countries: United States, Belgium, Czechia, Denmark, Estonia, Finland, France, Georgia, Germany, Greece, Italy, Japan, Netherlands, Norway, Portugal, Russia, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study