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

Headache, Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03887325
• Other study ID #: Maxipost P H-18052101
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: February 29, 2020

Study information

• Verified date: June 2020
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: February 29, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Headache, Migraine
• Migraine Disorders

Intervention

Drug:
• Maxipost
To investigate the role of maxipost on cerebral hemodynamic and headache in healthy volunteers and migraine patients
• Saline
To investigate the role of saline on cerebral hemodynamic and headache in healthy volunteers and migraine patients

Locations

Country	Name	City	State
Denmark	Danish headache center	Glostrup	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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