Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To investigate the migraine inducing effect of levcromakalim in patients with migraine with aura.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levcromakalim | Active Comparator |
| |
| Saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levcromakalim | Drug | To investigate the role of levcromakalim compared with placebo in migraine with aura patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Headache incidence | Difference in incidence of headache following infusion of levcromakalim compared to placebo in patients with migraine with aura. | 10 minutes before until 24 hours after infusion of levcromakalim or placebo |
| Migraine incidence | Difference in incidence of migraine-like headache following infusion of levcromakalim compared to placebo in patients with migraine with aura. | 10 minutes before until 24 hours after infusion of levcromakalim or placebo |
| Aura incidence | Difference in incidence of migraine aura following infusion of levcromakalim compared to placebo in patients with migraine with aura. | 10 minutes before until 24 hours after infusion of levcromakalim or placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Headache intensity | The area under the curve (AUC) for headache following infusion of levcromakalim compared to placebo in patients with migraine with aura | 10 minutes before until 24 hours after infusion of levcromakalim or placebo |
| Heart rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Messoud Ashina | Danish Headache Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danish Headache Center | Glostrup Municipality | Copenhagen | DK-2600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39161224 | Derived | Thomsen AV, Al-Karagholi MA, Hougaard A, Ostrowski SR, Ashina M. Effects of levcromakalim in patients with migraine aura without headache: An experimental study. Cephalalgia. 2024 Aug;44(8):3331024241274366. doi: 10.1177/03331024241274366. | |
| 38501895 | Derived | Thomsen AV, Al-Karagholi MA, Hougaard A, Ostrowski SR, Pedersen OB, Hansen TF, Ashina M. Investigations of the migraine-provoking effect of levcromakalim in patients with migraine with aura. Cephalalgia. 2024 Mar;44(3):3331024241237247. doi: 10.1177/03331024241237247. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019806 | Cromakalim |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Saline | Drug | To investigate the role of levcromakalim compared with placebo in migraine with aura patients |
|
Change in heart rate measured in Beats per minute (BPM) following infusion of levcromakalim compared to placebo in patients with migraine with aura
| 10 minutes before until 120 minutes after infusion of levcromakalim or placebo |
| Blood pressure | Change in blood pressure (systolic and diastolic) measured in mmHg following infusion of levcromakalim compared to placebo in patients with migraine with aura | 10 minutes before until 120 minutes after infusion of levcromakalim or placebo |
| D009422 | Nervous System Diseases |
| 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 |