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The study aims to explore the effects of Sumatriptan on Levcromakalim-induced migraine in individuals with migraine without aura.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levcromakalim | Drug | 20 min infusion of 1 mg Levcromakalim followed by either sumatriptan or placebo. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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: C. Headache has at least two of the following characteristics:
D. During headache at least one of the following:
(ii) Headache described as mimicking the patient's usual migraine attack and treated with acute migraine medication (rescue medication). | Assessed from baseline to 12 hours after infusion of levcromakalim. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed from baseline to 12 hours after infusion of levcromakalim. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of facial flushing | Incidence of facial skin flushing assessed by the investigator as a binary outcome. | Assessed from baseline to 2 hours after infusion of levcromakalim. |
| Facial blood flow assessed using Laser Doppler Flowmetry |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Messoud Ashina, Prof. | Danish Headache Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danish Headache Centre | Glostrup | Region Sjælland | 2600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40624944 | Derived | 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. |
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| ID | Term |
|---|---|
| D020326 | Migraine without Aura |
| D006261 | Headache |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D019806 | Cromakalim |
| D018170 | Sumatriptan |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Sumatriptan | Drug | 10 min infusion of 4 mg sumatriptan. |
|
| Saline | Drug | 10 min infusion of isotonic saline (placebo). |
|
| 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. |
| 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). | 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. | Assessed from baseline to 12 hours after infusion of levcromakalim. |
Facial blood flow is measured as a continuous outcome using Laser Doppler Flowmetry (LDI, Moor Instruments, Devon, United Kingdom).
| Assessed from baseline to 2 hours after infusion of levcromakalim. |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001578 |
| Benzopyrans |
| D011714 | Pyrans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |