Migraine Inducing Effect of Levcromakalim in Patients With Migraine With Aura

Study Overview
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Brief Summary
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To investigate the migraine inducing effect of levcromakalim in patients with migraine with aura.

Official Title
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Migraine Inducing Effect of Levcromakalim in Patients With Migraine With Aura

Conditions
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Headache, Migraine, Aura

Intervention / Treatment
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* Drug: Levcromakalim
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Migraine with aura patients of both sexes. 18-70 years. 50-100 kg. Exclusion Criteria: Headache less than 48 hours before the tests start Daily consumption of drugs of any kind that investigator deems might affect study results or safety. Pregnant or nursing women. Cardiovascular disease of any kind, including cerebrovascular diseases. Tension type headache (TTH) according to International Classification of Headache Disorders version 3 more than 5 times a month on average during the past year Known cluster headache according to International Classification of Headache Disorders version 3. Psychiatric disorder Smoking or abuse of drugs or alcohol Hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg) on day of inclusion. Hypotension (systolic blood pressure <90 mmHg and/or diastolic blood pressure <50 mmHg) on day of inclusion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Levcromakalim<br> | Drug: Levcromakalim<br>* To investigate the role of levcromakalim compared with placebo in migraine with aura patients<br>|
| Placebo Comparator: Saline<br> | Drug: Saline<br>* To investigate the role of levcromakalim compared with placebo in migraine with aura patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Levcromakalim