The Effects of Maxipost (BMS 204352) on Cerebral Hemodynamic and Headache in Healthy Volunteers and Migraine Patients

Study Overview
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Brief Summary
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It is not previously investigated whether, there is a correlation between potassium channels and migraine, so it is unclear whether, this signaling pathway through potassium channels has an impact on migraine pathophysiology. Maxipost (BMS 204352) is a vasoactive molecule that causes vasodilation via the big calcium dependent potassium (BKCa) channel signaling pathway. Maxipost decreases the blood pressure and maxipost infusion causes headache in healthy volunteers. A possible coherence between maxipost and headache/migraine in healthy volunteers and migraine patients is yet to be investigated. The present study aims to clarify a possible coherence between maxipost and headache/migraine and it will help to shed light on the importance of potassium channels in migraine. In general, the study will contribute to a greater understanding of migraine pathogenesis and possibly lead to development of specific migraine treatment.

Official Title
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To Investigate the Headache Induction and the Cerebral Hemodynamic Changes After Infusion of Maxipost in Healthy Volunteers and Migraine Patients

Conditions
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Headache, Migraine

Intervention / Treatment
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* Drug: Maxipost
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Migraine patients without aura who fulfill criteria in the international classification of headaches. This does not apply to healthy volunteers. 18-60 years. 50-90 kg. Women of childbearing potential must use adequate contraception. Exclusion Criteria: Headache less than 48 hours before the tests start All primary headaches, except migraine without aura for migraine patients, according to international classification of headache 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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Accepts Healthy Volunteers

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: Maxipost<br> | Drug: Maxipost<br>* To investigate the role of maxipost on cerebral hemodynamic and headache in healthy volunteers and migraine patients<br>|
| Placebo Comparator: Saline<br> | Drug: Saline<br>* To investigate the role of saline on cerebral hemodynamic and headache in healthy volunteers and migraine patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence and change of migraine attack | Occurrence and of migraine according to international criteria | Before (-10 minutes) and after infusion (+12 hours) of maxipost compared with before and after infusion of saline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cerebral hemodynamic | Change on velocity of media cerebri artery. | Before (-10 minutes) and after infusion (+2 hours) of maxipost compared with before and after infusion of saline | 
| Occurrence and change of headache | Occurrence of headache measured by numerical rating scale (NRS) | Before (-10 minutes) and after infusion (+12 hours) of maxipost compared with before and after infusion of saline | 
| Change of diameter of the artery | Change of diameter of superficial temporal artery and radial artery. The diameter will be measured by millimeter (mm). | Before (-10 minutes) and after infusion (+2 hours) of maxipost compared with before and after infusion of saline |