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

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

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.

Study Overview

• Status: Completed
• Conditions: Headache, Migraine
• Intervention / Treatment: Drug: Maxipost; Drug: Saline

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen
    • Glostrup, Copenhagen, Denmark, 2600
      • Danish Headache Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Saline	Drug: Saline; To investigate the role of saline on cerebral hemodynamic and headache in healthy volunteers and migraine patients
Active Comparator: Maxipost	Drug: Maxipost; To investigate the role of maxipost on cerebral hemodynamic and headache in healthy volunteers and migraine patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Danish Headache Center
• Investigators: Principal Investigator: Messoud A Ashina, Danish Headache Center

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): February 29, 2020
• Study Completion (Actual): February 29, 2020

Study Registration Dates

• First Submitted: March 18, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (Actual): March 22, 2019

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 11, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache
• Other Study ID Numbers: Maxipost P H-18052101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No