Cluster HeadacheNCT05093582
The Effects of Levcromakalim in Patients With Cluster Headache
A study testing Levcromakalim and Saline in people with Cluster Headache, run by Danish Headache Center at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cluster Headache
- What is being tested?
- Levcromakalim and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Jun 2021to 27 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Headache-inducing 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.
- Conditions
- Cluster Headache
- Being tested
- Levcromakalim, Saline
- Medical subject headings
- Cluster Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevcromakalimDrug
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.
SalineDrug
Also called Isotonic saline, 0.9% 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.
| Study group | Role | What they receive |
|---|---|---|
| Levcromakalim | Active comparator | Intravenous infusion of levcromakalim (1 mg/20 ml). The infusion is administered at constant speed by an automatic pump, lasting 20 minutes. Receives: Drug: Levcromakalim |
| Placebo | Placebo comparator | Intravenous infusion of placebo (sterile saline, 20 ml). The infusion is administered at constant speed by an automatic pump, lasting 20 minutes. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Severe unilateral pain lasting 15 to 180 minutes.
- Either or both of the following:
- At least 1 cephalic autonomic symptom ipsilateral to the headache.
- A sense of restlessness or agitation.
Measured: Change from baseline at 90 minutes after drug administration
Secondary outcomes (2)
Occurrence of headache
Yes/no questions.
Measured: Change from baseline at 90 minutes after drug administration
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.
Measured: Change from baseline at 90 minutes after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start4 Jun 2021
- Primary completion27 Sep 2022
- Study completion27 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cluster HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Messoud Ashina, MD, Danish Headache Center
- Investigators
- Messoud Ashina, MD, PhD, Principal investigator, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093582
- Sponsor's protocol ID
- H20082689
- Status last verified
- Jun 2023
- First submitted
- 17 Sep 2021
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38127692
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Headache-inducing Effects of Levcromakalim in Patients With Cluster Headache
- ClinicalTrials.gov ID
- NCT05093582
- Acronym / sponsor ID
- H20082689
- Conditions
- Cluster Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- 27 Sep 2022 (actual)
- Study completion
- 27 Sep 2022 (actual)
- First posted
- 26 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levcromakalim | Active comparator | Drug: LevcromakalimIntravenous infusion of levcromakalim (1 mg/20 ml). The infusion is administered at constant speed by an automatic pump, lasting 20 minutes. |
| Placebo | Placebo comparator | Drug: SalineIntravenous infusion of placebo (sterile saline, 20 ml). The infusion is administered at constant speed by an automatic pump, lasting 20 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levcromakalim12 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 | Levcromakalim |
| SalineAlso: Isotonic saline, 0.9% saline12 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 | Placebo |
Primary outcome
Occurrence of cluster headache attacks
Time frame: Change from baseline at 90 minutes after drug administration
Experimentally induced cluster headache attacks must fulfill either: 1. Headache described as mimicking the patient's usual cluster headache attack (with or without cephalic autonomic symptom). 2. 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.
2 secondary outcomes
Occurrence of headache
Time frame: Change from baseline at 90 minutes after drug administration
Change of headache intensity scores
Time frame: Change from baseline at 90 minutes after drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Derived from this study: PubMed 38127692Al-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Messoud Ashina, MD, PhD principal investigator
Danish Headache Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levcromakalim and Saline in people with Cluster Headache, run by Danish Headache Center at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of cluster headache attacks (time frame: Change from baseline at 90 minutes after drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05093582, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.