The Effects of Levcromakalim in Patients With Cluster Headache

Cluster Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05093582
• Other study ID #: H20082689
• Status: Completed
• Phase: N/A
• Start date: June 4, 2021
• Est. completion date: September 27, 2022

Study information

• Verified date: June 2023
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 27, 2022
• Est. primary completion date: September 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Cluster headache patients meeting ICHD-3 criteria for episodic and chronic cluster headache of either sex. Patients were defined as having episodic cluster headache in the active phase when they had usual attacks within the last 30 days, episodic cluster headache in the remission phase when they were attack-free for at least 30 days, or chronic cluster headache when they had not had more than 30 consecutively attack-free days over the last 12 months or longer.

• Weight between 50 and 100 kg.

• All preventive medications, except steroid treatments or greater occipital nerve blockade within 30 days, were allowed with stable dosing.

• Negative urinary HCG at baseline.

Exclusion Criteria:

• Primary headache types except above.

• Secondary headache disorders, according to ICHD-3.

• Headache at baseline.

• Anamnestic information or clinical signs of (at inclusion date) hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg) or hypotension (systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 50 mmHg)

• Known severe or treatment-requiring cardiovascular disease including cerebrovascular disease.

• Anamnestic or clinical evidence of mental disorder or substance abuse.

• Anamnestic or clinical evidence of any disease considered by the investigating physician to be relevant to participation in the study.

• Pregnant or lactating women.

Related Conditions & MeSH terms

• Cluster Headache
• Headache

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Danish Headache Center	Glostrup	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of cluster headache attacks	Experimentally induced cluster headache attacks must fulfill either: Headache described as mimicking the patient's usual cluster headache attack (with or without cephalic autonomic symptom).; Headache fulfilling criteria A and B for cluster headache according to International Classification of Headache Disorders criteria: A. Severe unilateral pain lasting 15 to 180 minutes.; B. Either or both of the following: At least 1 cephalic autonomic symptom ipsilateral to the headache.; A sense of restlessness or agitation.	Change from baseline at 90 minutes after drug administration
Secondary	Occurrence of headache	Yes/no questions.	Change from baseline at 90 minutes after drug administration
Secondary	Change of headache intensity scores	Headache intensity scores are measured by a numerical rating scale (NRS). It is a verbally declared scale from 0 to 10, where 0 is no headache; 1 is a very mild headache, including a feeling of pressing or throbbing; 5 is a moderate headache; 10 is the worst imaginable headache.	Change from baseline at 90 minutes after drug administration