NCT05093582

The Effects of Levcromakalim in Patients With Cluster Headache

The Headache-inducing Effects of Levcromakalim in Patients With Cluster Headache

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Danish Headache Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Cluster headache is a primary headache disorder characterized by attacks of unilateral headache of short duration and severe pain intensity. There is an unmet need to understand the underlying disease mechanisms that will ultimately lead to the development of disease-specific medicines. Until now, it has been suggested that the calcitonin gene-related peptide (CGRP) plays a major role in the initiation of a cluster headache attack, possibly involving the ATP-sensitive potassium channels. The current study aims to determine whether the opening of ATP-sensitive potassium channels triggers cluster headache attacks in patients with cluster headache.

Conditions

• Cluster Headache

Interventions

Type	Name	Description
DRUG	Levcromakalim	12 active episodic patients, 15 episodic patients in remission and 20 chronic patients of both genders are randomized to receive a 20-minute infusion of levcromakalim and/or sterile saline on two days, with at least 3 days in between.
DRUG	Saline	12 active episodic patients, 15 episodic patients in remission and 20 chronic patients of both genders are randomized to receive a 20-minute infusion of levcromakalim and/or sterile saline on two days, with at least 3 days in between.

Timeline

• Start date: 2021-06-04
• Primary completion: 2022-09-27
• Completion: 2022-09-27
• First posted: 2021-10-26
• Last updated: 2023-06-28

Locations

1 site across 1 country: Denmark