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

Not Applicable

Completed

• Conditions: Headache, Migraine
• Interventions: Drug: Saline; Drug: Maxipost

• Registration Number: NCT03887325
• Lead Sponsor: Danish Headache Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-18
• Study First Submitted QC: 2019-03-21
• Study First Posted: 2019-03-22
• Study Start: 2019-04-01
• Primary Completion: 2020-02-29
• Study Completion: 2020-02-29
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-11
• Last Update Posted: 2020-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Saline	Saline	-
Maxipost	Maxipost	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Danish headache center; 🇩🇰 Glostrup, Copenhagen, Denmark