Headache, Migraine
Conditions
Brief summary
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.
Interventions
DRUGMaxipost
To investigate the role of maxipost on cerebral hemodynamic and headache in healthy volunteers and migraine patients
DRUGSaline
To investigate the role of saline on cerebral hemodynamic and headache in healthy volunteers and migraine patients
Sponsors
Danish Headache Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence and change of migraine attack | Before (-10 minutes) and after infusion (+12 hours) of maxipost compared with before and after infusion of saline | Occurrence and of migraine according to international criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in cerebral hemodynamic | Before (-10 minutes) and after infusion (+2 hours) of maxipost compared with before and after infusion of saline | Change on velocity of media cerebri artery. |
| Occurrence and change of headache | Before (-10 minutes) and after infusion (+12 hours) of maxipost compared with before and after infusion of saline | Occurrence of headache measured by numerical rating scale (NRS) |
| Change of diameter of the artery | Before (-10 minutes) and after infusion (+2 hours) of maxipost compared with before and after infusion of saline | Change of diameter of superficial temporal artery and radial artery. The diameter will be measured by millimeter (mm). |
Countries
Denmark
Outcome results
None listed