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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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An outstanding scientific question, that merits further investigation, is whether dilation of intracranial arteries is implicated in the pathogenesis of cephalic pain in migraine. Here, we hypothesize that experimentally-induced dilation of intracranial arteries using intravenous infusion of levcromakalim (a potent vasodilator) induces cephalic pain with migraine-like features in people with migraine, who prior to the infusion are administered erenumab (anti-calcitonin gene-related peptide (CGRP) receptor monoclonal antibody).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levcromakalim | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levcromakalim | Drug | Continuous intravenous infusion of 20 mL levcromakalim (0.05 mg/min (50 μg/ mL) over 20 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of migraine attack | Difference in incidence of migraine attack (0 to 12 hours) between levcromakalim and placebo. 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 Headache Society criteria: 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 verbal 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). | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of headache | Difference in incidence of headache (0 to 12 hours) between levcromakalim and placebo. 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; 10 is the worst pain imaginable. | 12 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danish Headache Center | Copenhagen | 2600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38181724 | Derived | Raffaelli B, Do TP, Chaudhry BA, Amin FM, Ashina H, Snellman J, Maio-Twofoot T, Ashina M. Activation of ATP-sensitive potassium channels triggers migraine attacks independent of calcitonin gene-related peptide receptors: a randomized placebo-controlled trial. Cephalalgia. 2024 Jan;44(1):3331024231222916. doi: 10.1177/03331024231222916. |
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| ID | Term |
|---|---|
| D020326 | Migraine without Aura |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D019806 | Cromakalim |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Other | Continuous intravenous infusion of 20 mL isotonic saline over 20 minutes |
|
| Intensity of headache |
Difference in area under the curve (AUC) for headache intensity scores (0 to 12 hours) between levcromakalim and placebo. 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; 10 is the worst pain imaginable. |
| 12 hours |
| Diameter of superficial temporal artery | Diameter (mm) of superficial temporal artery is measured as a continuous outcome. | 1 hour |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001578 |
| Benzopyrans |
| D011714 | Pyrans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |