NCT04970355

Efficacy of Erenumab in Chronic Cluster Headache

Efficacy of Erenumab in Chronic Cluster Headache: A 10 Week Double-blind, Randomized, Placebo Controlled, Multicentric Trial.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to evaluate the efficacy of erenumab in participants with chronic cluster headache.

Detailed description

The purpose of this study is to determine the efficacy of erenumab in a loading dose of 280mg followed by 140mg after 4 weeks compared to placebo as a prophylactic treatment in patients with chronic cluster headache. This study has a 10-week 2-arm, randomized, double-blind, parallel- group, placebo-controlled design. Data from this study will provide important information if the blockade of the CGRP receptor with erenumab is an efficacious principle for the treatment of chronic cluster headache

Conditions

• Cluster Headache
• Trigeminal Autonomic Cephalalgias
• Headache Disorders, Primary
• Brain Disease

Interventions

Type	Name	Description
BIOLOGICAL	Erenumab	Pre-filled syringe; s.c. injection
DRUG	Placebo	Pre-filled syring; s.c. injection

Timeline

• Start date: 2021-12-02
• Primary completion: 2023-09-27
• Completion: 2023-09-27
• First posted: 2021-07-21
• Last updated: 2024-01-23

Locations

11 sites across 1 country: Germany

Regulatory

• FDA-regulated drug study