The Effects of Maxipost (BMS 204352) on Cerebral Hemodynamic and Headache in Healthy Volunteers and Migraine Patients
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|ClinicalTrials.gov Identifier: NCT03887325|
Recruitment Status : Completed
First Posted : March 22, 2019
Last Update Posted : June 16, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Headache, Migraine||Drug: Maxipost Drug: Saline||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||To Investigate the Headache Induction and the Cerebral Hemodynamic Changes After Infusion of Maxipost in Healthy Volunteers and Migraine Patients|
|Actual Study Start Date :||April 1, 2019|
|Actual Primary Completion Date :||February 29, 2020|
|Actual Study Completion Date :||February 29, 2020|
|Active Comparator: Maxipost||
To investigate the role of maxipost on cerebral hemodynamic and headache in healthy volunteers and migraine patients
|Placebo Comparator: Saline||
To investigate the role of saline on cerebral hemodynamic and headache in healthy volunteers and migraine patients
- Occurrence and change of migraine attack [ Time Frame: 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
- Change in cerebral hemodynamic [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03887325
|Danish headache center|
|Glostrup, Copenhagen, Denmark, 2600|
|Principal Investigator:||Messoud A Ashina||Danish Headache Center|