Migraine Without AuraSLIMNCT05211050
Effect of Sumatriptan on Levcromakalim-Induced Symptoms in Individuals With Migraine
A study testing Levcromakalim, Sumatriptan and Saline in people with Migraine Without Aura and Headache, run by Danish Headache Center at 1 site in Denmark.
Trial summary
The study aims to explore the effects of Sumatriptan on Levcromakalim-induced migraine in individuals with migraine without aura. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Without Aura, Headache
- What is being tested?
- Levcromakalim, Sumatriptan and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Mar 2022to 5 Nov 2023
- 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
- Participant has provided informed consent prior to initiation of any study-specific activities/procedures.
- Age ≥18 years upon entry into screening.
- History of migraine without aura for ≥12 months with a frequency of 1-5 migraine attacks per month before screening according to the International Headache Society (IHS) Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018), based on medical records and/or patient self-report.
Who cannot join
- History of any primary headache disorder other than migraine without aura, or tension-type headache with a frequency of ≥5 headache days per month before screening according to the International Headache Society (IHS) Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018), based on medical records and/or patient self-report.
- History of any secondary headache disorder before screening according to the International Headache Society (IHS) Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018) based on medical records and/or patient self-report.
- Any headache 48 hours prior to, or any migraine 72 hours prior to the start of the experiment on day 1 and 2.
- Daily consumption of any drug/medication other than oral contraception (birth control).
- Intake of prophylactic migraine medication within ≤30 days or 5 plasma half-lives (whichever is longer) prior to screening.
- The participant is at risk of self-harm or harm to others as evidenced by past suicidal behavior.
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- History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator will pose a risk to participant safety or interfere with the study evaluation, procedures or completion.
- Female participants of childbearing potential with a positive pregnancy test assessed at screening or day 1 by a urine pregnancy test.
- Female participants who are pregnant or breastfeeding or plan to become pregnant or breastfeed during participation in the study.
- Evidence of current pregnancy or breastfeeding per participant self-report or medical records.
- Participants likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participants' and investigator's knowledge.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Sumatriptan on Levcromakalim-Induced Symptoms in Individuals With Migraine: A Randomized Double-Blind Two-Way Crossover Study
The study aims to explore the effects of Sumatriptan on Levcromakalim-induced migraine in individuals with migraine without aura.
Read the detailed description
Opening of adenosine triphosphate-sensitive potassium (KATP) channels using Levcromakalim causes migraine attacks with and without aura in a high proportion of patients.
Sumatriptan has been shown to reverse Levcromakalim-induced dilation of the middle meningeal artery and headache in healthy volunteers, indicating that Sumatriptan can overturn the physiological effects of levcromakalim.
The study aims to explore the effects of Sumatriptan on Levcromakalim-induced migraine in individuals with migraine without aura.
- Conditions
- Migraine Without Aura, Headache
- Being tested
- Levcromakalim, Sumatriptan, Saline
- Medical subject headings
- Migraine without Aura, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevcromakalimDrug
20 min infusion of 1 mg Levcromakalim followed by either sumatriptan or placebo.
SumatriptanDrug
10 min infusion of 4 mg sumatriptan.
SalineDrug
10 min infusion of isotonic saline (placebo).
| Study group | Role | What they receive |
|---|---|---|
| Levcromakalim-Sumatriptan | Active comparator | 20 participants with migraine without aura will receive a 20 min infusion of levcromakalim followed by a 10 min infusion of sumatriptan. Receives: Drug: Levcromakalim; Drug: Sumatriptan |
| Levcromakalim-Placebo | Placebo comparator | 20 participants with migraine without aura will receive a 20 min infusion of levcromakalim followed by a 10 min infusion of saline. Receives: Drug: Levcromakalim; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of migraine attacks
A migraine attack is defined as an attack fulfilling either (i) or (ii):
(i) Headache fulfilling criteria C and D for migraine without aura according to the International Classification of Headache Disorders 3rd edition:
- Headache has at least two of the following characteristics:
- unilateral location
- pulsating quality
- moderate or severe pain intensity (moderate to severe pain intensity is considered ≥4 on the numerical rating scale)
- aggravation by cough (in-hospital phase) or causing avoidance of routine physical activity (out-hospital phase)
- During headache at least one of the following:
- nausea and/or vomiting
- photophobia and phonophobia (ii) Headache described as mimicking the patient's usual migraine attack and treated with acute migraine medication (rescue medication).
Measured: Assessed from baseline to 12 hours after infusion of levcromakalim.
Secondary outcomes (4)
Incidence of headache
Incidence of headache is defined as headache intensity ≥1 as measured by a numerical rating scale (NRS) from 0 to 10. It is a verbally declared scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.
Measured: Assessed from baseline to 12 hours after infusion of levcromakalim.
Intensity of headache
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 pain and 10 is the worst pain imaginable.
Measured: Assessed from baseline to 12 hours after infusion of levcromakalim.
Diameter of superficial temporal artery (STA) assessed using high frequency ultrasound
Diameter (mm) of superficial temporal artery (STA) is measured as a continuous outcome using high frequency ultrasound (Dermascan C, Cortex Technology, Denmark).
Measured: Assessed from baseline to 2 hours after infusion of levcromakalim.
Incidence of adverse events
Participants are instructed to inform the investigators in the case of adverse events.
Measured: Assessed from baseline to 12 hours after infusion of levcromakalim.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start15 Mar 2022
- Primary completion5 Nov 2023
- Study completion5 Nov 2023
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 Migraine Without AuraStudies 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
- 24 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, Prof., Principal investigator, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211050
- Sponsor's protocol ID
- H-21011542
- Acronym
- SLIM
- Status last verified
- Jan 2025
- First submitted
- 4 Jan 2022
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhuang ZA, Al-Karagholi MA, Ashina H, Do TP, Ashina M. Effect of sumatriptan on ATP-sensitive potassium channel opening in migraine: A randomised controlled trial. Cephalalgia. 2025 Jul;45(7):3331024251341464. doi: 10.1177/03331024251341464. Epub 2025 Jul 7.
PubMed 40624944
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sumatriptan on Levcromakalim-Induced Symptoms in Individuals With Migraine: A Randomized Double-Blind Two-Way Crossover Study
- ClinicalTrials.gov ID
- NCT05211050
- Acronym / sponsor ID
- SLIM / H-21011542
- Conditions
- Migraine Without Aura, Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 5 Nov 2023 (actual)
- Study completion
- 5 Nov 2023 (actual)
- First posted
- 27 Jan 2022 (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.
The study aims to explore the effects of Sumatriptan on Levcromakalim-induced migraine in individuals with migraine without aura.
Detailed description
Opening of adenosine triphosphate-sensitive potassium (KATP) channels using Levcromakalim causes migraine attacks with and without aura in a high proportion of patients.
Sumatriptan has been shown to reverse Levcromakalim-induced dilation of the middle meningeal artery and headache in healthy volunteers, indicating that Sumatriptan can overturn the physiological effects of levcromakalim.
The study aims to explore the effects of Sumatriptan on Levcromakalim-induced migraine in individuals with migraine without aura.
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-Sumatriptan | Active comparator | Drug: Levcromakalim, Drug: Sumatriptan20 participants with migraine without aura will receive a 20 min infusion of levcromakalim followed by a 10 min infusion of sumatriptan. |
| Levcromakalim-Placebo | Placebo comparator | Drug: Levcromakalim, Drug: Saline20 participants with migraine without aura will receive a 20 min infusion of levcromakalim followed by a 10 min infusion of saline. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant has provided informed consent prior to initiation of any study-specific activities/procedures.
- Age ≥18 years upon entry into screening.
- History of migraine without aura for ≥12 months with a frequency of 1-5 migraine attacks per month before screening according to the International Headache Society (IHS) Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018), based on medical records and/or patient self-report.
Key exclusion criteria (11 listed)
- History of any primary headache disorder other than migraine without aura, or tension-type headache with a frequency of ≥5 headache days per month before screening according to the International Headache Society (IHS) Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018), based on medical records and/or patient self-report.
- History of any secondary headache disorder before screening according to the International Headache Society (IHS) Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018) based on medical records and/or patient self-report.
- Any headache 48 hours prior to, or any migraine 72 hours prior to the start of the experiment on day 1 and 2.
- Daily consumption of any drug/medication other than oral contraception (birth control).
- Intake of prophylactic migraine medication within ≤30 days or 5 plasma half-lives (whichever is longer) prior to screening.
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 |
|---|---|---|
| Levcromakalim20 min infusion of 1 mg Levcromakalim followed by either sumatriptan or placebo. | Drug | Levcromakalim-Placebo, Levcromakalim-Sumatriptan |
| Sumatriptan10 min infusion of 4 mg sumatriptan. | Drug | Levcromakalim-Sumatriptan |
| Saline10 min infusion of isotonic saline (placebo). | Drug | Levcromakalim-Placebo |
Primary outcome
Incidence of migraine attacks
Time frame: Assessed from baseline to 12 hours after infusion of levcromakalim.
A migraine attack is defined as an attack fulfilling either (i) or (ii): (i) Headache fulfilling criteria C and D for migraine without aura according to the International Classification of Headache Disorders 3rd edition: C. Headache has at least two of the following characteristics: * unilateral location * pulsating quality * moderate or severe pain intensity (moderate to severe pain intensity is considered ≥4 on the numerical rating scale) * aggravation by cough (in-hospital phase) or causing avoidance of routine physical activity (out-hospital phase) D. During headache at least one of the following: * nausea and/or vomiting * photophobia and phonophobia (ii) Headache described as mimicking the patient's usual migraine attack and treated with acute migraine medication (rescue medication).
4 secondary outcomes
Incidence of headache
Time frame: Assessed from baseline to 12 hours after infusion of levcromakalim.
Intensity of headache
Time frame: Assessed from baseline to 12 hours after infusion of levcromakalim.
Diameter of superficial temporal artery (STA) assessed using high frequency ultrasound
Time frame: Assessed from baseline to 2 hours after infusion of levcromakalim.
Incidence of adverse events
Time frame: Assessed from baseline to 12 hours after infusion of levcromakalim.
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 22 Jan 2025.
- Derived from this study: PubMed 40624944Zhuang ZA, Al-Karagholi MA, Ashina H, Do TP, Ashina M. Effect of sumatriptan on ATP-sensitive potassium channel opening in migraine: A randomised controlled trial. Cephalalgia. 2025 Jul;45(7):3331024251341464. doi: 10.1177/03331024251341464. Epub 2025 Jul 7.
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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, Prof. 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, Sumatriptan and Saline in people with Migraine Without Aura and 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 3 inclusion and 11 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 22 Jan 2025. 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?
Incidence of migraine attacks (time frame: Assessed from baseline to 12 hours after infusion of levcromakalim.). 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 NCT05211050, 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 22 Jan 2025.