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NCT Number: NCT03887325

The Effects of Maxipost (BMS 204352) on Cerebral Hemodynamic and Headache 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.

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Key information

Conditions

Headache, Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danish headache center

Glostrup Municipality, Copenhagen, 2600, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Maxipost

Drug

To investigate the role of maxipost on cerebral hemodynamic and headache in healthy volunteers and migraine patients

Saline

Drug

To investigate the role of saline on cerebral hemodynamic and headache in healthy volunteers and migraine patients

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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)

  3. 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).

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 22, 2019
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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