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

Danish Headache Center43 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Headache, Migraine

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Occurrence and change of migraine attack

Occurrence and of migraine according to international criteria

Time frame: Before (-10 minutes) and after infusion (+12 hours) of maxipost compared with before and after infusion of saline

Secondary Outcomes

Change in cerebral hemodynamic

Change on velocity of media cerebri artery.

Time frame: 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)