Clinical trial NCT03887325: The Effects of Maxipost (BMS 204352) on Cerebral Hemodynamic and Headache in Healthy Volunteers and Migraine Patients
Official title: To Investigate the Headache Induction and the Cerebral Hemodynamic Changes After Infusion of Maxipost in Healthy Volunteers and Migraine Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache, Migraine
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2019-03-22
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Occurrence and change of migraine attack
timeFrame: Before (-10 minutes) and after infusion (+12 hours) of maxipost compared with before and after infusion of saline
Secondary outcomes:
measure: Change in cerebral hemodynamic
timeFrame: Before (-10 minutes) and after infusion (+2 hours) of maxipost compared with before and after infusion of saline
measure: Occurrence and change of headache
timeFrame: Before (-10 minutes) and after infusion (+12 hours) of maxipost compared with before and after infusion of saline
measure: Change of diameter of the artery
timeFrame: Before (-10 minutes) and after infusion (+2 hours) of maxipost compared with before and after infusion of saline
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish headache center
state: Copenhagen
Study officials:
affiliation: Danish Headache Center
name: Messoud A Ashina
role: PRINCIPAL_INVESTIGATOR
References:
citation: Al-Karagholi MA, Ghanizada H, Waldorff Nielsen CA, Skandarioon C, Snellman J, Lopez-Lopez C, Hansen JM, Ashina M. Opening of BKCa channels causes migraine attacks: a new downstream target for the treatment of migraine. Pain. 2021 Oct 1;162(10):2512-2520. doi: 10.1097/j.pain.0000000000002238.
citation: Al-Karagholi MA, Ghanizada H, Nielsen CAW, Skandarioon C, Snellman J, Lopez Lopez C, Hansen JM, Ashina M. Opening of BKCa channels alters cerebral hemodynamic and causes headache in healthy volunteers. Cephalalgia. 2020 Oct;40(11):1145-1154. doi: 10.1177/0333102420940681. Epub 2020 Aug 26.