Skip to main content
OpenTrials
Completed

NCT Number: NCT04012047

Headache Inducing Effect of Levcromakalim in Migraine With Aura Patients

To investigate the role of KATP channels in migraine with aura patients.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Headache Aura Brain Diseases Central Nervous System Diseases Epilepsy Headache Disorders Headache Disorders, Primary Migraine Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danish headache center

Glostrup Municipality, 2600, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Migraine with aura patients of both sexes.
  • 18-60 years.
  • 50-100 kg.

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 compared with placebo in migraine with aura patients

Saline

Drug

To investigate the role of levcromakalim compared with placebo in migraine with aura patients

Primary outcomes

  1. Headache

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

    Occurrence of headache

  2. Migraine

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

    Occurrence of migraine

  3. Aura

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

    Occurrence of aura

Secondary outcomes

  1. The area under the curve (AUC) for headache

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

    Headache intensity

  2. Family history

    Time frame: After including the patients in the study.

    Direct interview with the 1 st degree family memeber for included patients according to international classification of headaches.

  3. Heart rate

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

    Change in heart rate measured in Beats per minute (BPM)

  4. Blood pressure

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

    Change in blood pressure measured in mmHg

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 9, 2019
Registry last updated
Mar 2, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.