The Effects of Levcromakalim in Patients With Cluster Headache

NCT ID: NCT05093582

Last Updated: 2023-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-04
• Study Completion Date: 2022-09-27

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Levcromakalim

Intravenous infusion of levcromakalim (1 mg/20 ml). The infusion is administered at constant speed by an automatic pump, lasting 20 minutes.

Group Type: ACTIVE_COMPARATOR

Levcromakalim

Intervention Type: DRUG

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.

Placebo

Intravenous infusion of placebo (sterile saline, 20 ml). The infusion is administered at constant speed by an automatic pump, lasting 20 minutes.

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Isotonic saline; 0.9% saline

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Danish Headache Center

OTHER

Sponsor Role: lead

Responsible Party

Messoud Ashina, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Messoud Ashina, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Danish Headache Center

Locations

Danish Headache Center

Glostrup Municipality, Copenhagen, Denmark

Countries

Denmark

References

Al-Khazali HM, Deligianni CI, Pellesi L, Al-Karagholi MA, Ashina H, Chaudhry BA, Petersen AS, Jensen RH, Amin FM, Ashina M. Induction of cluster headache after opening of adenosine triphosphate-sensitive potassium channels: a randomized clinical trial. Pain. 2024 Jun 1;165(6):1289-1303. doi: 10.1097/j.pain.0000000000003130. Epub 2023 Dec 19.

Reference Type: DERIVED

PMID: 38127692 (View on PubMed)

Other Identifiers

H20082689

Identifier Type: -

Identifier Source: org_study_id