Headache Inducing Effect of Levcromakalim in Migraine With Aura Patients

Study Overview
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Brief Summary
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To investigate the role of KATP channels in migraine with aura patients.

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

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. 18-60 years. 50-100 kg. Exclusion Criteria: Headache less than 48 hours before the tests start Daily consumption of drugs of any kind other than oral contraceptives Pregnant or nursing women. Cardiovascular disease of any kind, including cerebrovascular diseases.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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 | Occurrence of headache | Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline | 
| Migraine | Occurrence of migraine | Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline | 
| Aura | Occurrence of aura | Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The area under the curve (AUC) for headache | Headache intensity | Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline | 
| Family history | Direct interview with the 1 st degree family memeber for included patients according to international classification of headaches. | After including the patients in the study. | 
| Heart rate | Change in heart rate measured in Beats per minute (BPM) | Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline | 
| Blood pressure | Change in blood pressure measured in mmHg | Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline | 

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