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The aim is to investigate whether opening of ATP-sensitive potassium (KATP) channels induces headache with migraine-like features in people with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (mTBI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levcromakalim | Experimental | A time- and volume-controlled infusion pump is used to administer levcromakalim by intravenous infusion over 20 minutes. |
|
| Placebo (isotonic saline) | Placebo Comparator | A time- and volume-controlled infusion pump is used to administer placebo (isotonic saline) by intravenous infusion over 20 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levcromakalim | Drug | Study participants will be allocated to receive continuous intravenous infusion of 0.05 mg/min (20 ml of 50 mg/ml) levcromakalim. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Migraine-Like Headache | Difference in incidence of headache with migraine-like features (0 to 12 hours) between levcromakalim and placebo. | 12 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Headache Intensity Scores | Difference in area under the curve (AUC) for headache intensity scores (0 to 12 hours) between levcromakalim and placebo. | 12 Hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hakan Ashina, MD | Danish Headache Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danish Headache Center | Copenhagen | 2600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37917826 | Derived | Al-Khazali HM, Christensen RH, Dodick DW, Chaudhry BA, Burstein R, Ashina H. Hypersensitivity to opening of ATP-sensitive potassium channels in post-traumatic headache. Cephalalgia. 2023 Nov;43(11):3331024231210930. doi: 10.1177/03331024231210930. |
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| ID | Term |
|---|---|
| D051298 | Post-Traumatic Headache |
| D006261 | Headache |
| D010146 | Pain |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D019806 | Cromakalim |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Study participants will be allocated to receive continuous intravenous infusion of 20 mL placebo (isotonic saline). |
|
|
| D009422 | Nervous System Diseases |
| 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 |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |