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Completed

NCT Number: NCT03228355

Headache Inducing Effect of Cromakalim in Migraine Patients

To investigate the role of KATP channels on the cerebral hemodynamic in migraine patients.

Completed

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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

Copenhagen, Glostrup, 2600, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Migraine patients of both sexes.
  • 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
  • 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

Levcromakalim

Drug

To investigate the role of Levcromakalim on cerebral hemodynamic in migraine patients

Saline

Drug

To investigate the role of levcromakalim compared with saline cerebral hemodynamic in migraine patients.

Primary outcomes

  1. Cerebral hemodynamic

    Time frame: Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline

    Change on Media cerebri arterie.

  2. Headache

    Time frame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline

    Occurrence of headache.

  3. Migraine attack

    Time frame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline

    Occurrence

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Official study title

The Effects of Levcromakalim on Cerebral Hemodynamic in Migraine Patients

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 24, 2017
Registry last updated
Jun 19, 2018

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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