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OpenTrials
Completed

NCT Number: NCT05093582

The Effects of Levcromakalim in Patients With Cluster Headache

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.

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Key information

Conditions

Cluster Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases Trigeminal Autonomic Cephalalgias

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danish Headache Center

Glostrup Municipality, Copenhagen, 2600, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levcromakalim

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.

Saline

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.

Other names: Isotonic saline, 0.9% saline

Primary outcomes

  1. Occurrence of cluster headache attacks

    Time frame: Change from baseline at 90 minutes after drug administration

    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.

Secondary outcomes

  1. Occurrence of headache

    Time frame: Change from baseline at 90 minutes after drug administration

    Yes/no questions.

  2. Change of headache intensity scores

    Time frame: Change from baseline at 90 minutes after drug administration

    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.

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 26, 2021
Registry last updated
Jun 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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