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The Effects of Levcromakalim in Patients With Cluster Headache

Primary Purpose

Cluster Headache

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Levcromakalim
Saline
Sponsored by
Danish Headache Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cluster Headache

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Danish Headache Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Levcromakalim

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Occurrence of headache
Yes/no questions.
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.

Full Information

First Posted
September 17, 2021
Last Updated
June 27, 2023
Sponsor
Danish Headache Center
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1. Study Identification

Unique Protocol Identification Number
NCT05093582
Brief Title
The Effects of Levcromakalim in Patients With Cluster Headache
Official Title
The Headache-inducing Effects of Levcromakalim in Patients With Cluster Headache
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 4, 2021 (Actual)
Primary Completion Date
September 27, 2022 (Actual)
Study Completion Date
September 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Headache Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cluster Headache

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levcromakalim
Arm Type
Active Comparator
Arm Description
Intravenous infusion of levcromakalim (1 mg/20 ml). The infusion is administered at constant speed by an automatic pump, lasting 20 minutes.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intravenous infusion of placebo (sterile saline, 20 ml). The infusion is administered at constant speed by an automatic pump, lasting 20 minutes.
Intervention Type
Drug
Intervention Name(s)
Levcromakalim
Intervention Description
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
Intervention Name(s)
Saline
Other Intervention Name(s)
Isotonic saline, 0.9% saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Occurrence of cluster headache attacks
Description
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.
Time Frame
Change from baseline at 90 minutes after drug administration
Secondary Outcome Measure Information:
Title
Occurrence of headache
Description
Yes/no questions.
Time Frame
Change from baseline at 90 minutes after drug administration
Title
Change of headache intensity scores
Description
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.
Time Frame
Change from baseline at 90 minutes after drug administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Messoud Ashina, MD, PhD
Organizational Affiliation
Danish Headache Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danish Headache Center
City
Glostrup
State/Province
Copenhagen
ZIP/Postal Code
2600
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effects of Levcromakalim in Patients With Cluster Headache

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