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Completed

NCT Number: NCT04905654

Migraine Inducing Effect of Levcromakalim in Patients With Migraine With Aura

To investigate the migraine inducing effect of levcromakalim in patients with migraine with aura.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danish Headache Center

Glostrup Municipality, Copenhagen, DK-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.
  • 18-70 years.
  • 50-100 kg.

Exclusion criteria

  • Headache less than 48 hours before the tests start
  • Daily consumption of drugs of any kind that investigator deems might affect study results or safety.
  • Pregnant or nursing women.
  • Cardiovascular disease of any kind, including cerebrovascular diseases.
  • Tension type headache (TTH) according to International Classification of Headache Disorders version 3 more than 5 times a month on average during the past year
  • Known cluster headache according to International Classification of Headache Disorders version 3.
  • Psychiatric disorder
  • Smoking or abuse of drugs or alcohol
  • Hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg) on day of inclusion.
  • Hypotension (systolic blood pressure <90 mmHg and/or diastolic blood pressure <50 mmHg) on day of inclusion.

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 incidence

    Time frame: 10 minutes before until 24 hours after infusion of levcromakalim or placebo

    Difference in incidence of headache following infusion of levcromakalim compared to placebo in patients with migraine with aura.

  2. Migraine incidence

    Time frame: 10 minutes before until 24 hours after infusion of levcromakalim or placebo

    Difference in incidence of migraine-like headache following infusion of levcromakalim compared to placebo in patients with migraine with aura.

  3. Aura incidence

    Time frame: 10 minutes before until 24 hours after infusion of levcromakalim or placebo

    Difference in incidence of migraine aura following infusion of levcromakalim compared to placebo in patients with migraine with aura.

Secondary outcomes

  1. Headache intensity

    Time frame: 10 minutes before until 24 hours after infusion of levcromakalim or placebo

    The area under the curve (AUC) for headache following infusion of levcromakalim compared to placebo in patients with migraine with aura

  2. Heart rate

    Time frame: 10 minutes before until 120 minutes after infusion of levcromakalim or placebo

    Change in heart rate measured in Beats per minute (BPM) following infusion of levcromakalim compared to placebo in patients with migraine with aura

  3. Blood pressure

    Time frame: 10 minutes before until 120 minutes after infusion of levcromakalim or placebo

    Change in blood pressure (systolic and diastolic) measured in mmHg following infusion of levcromakalim compared to placebo in patients with migraine with aura

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 27, 2021
Registry last updated
May 17, 2023

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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