Headache Inducing Effect of Levcromakalim in Migraine With Aura Patients

N/ACompletedNCT04012047

Danish Headache Center17 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Headache Migraine Aura

Interventions

LevcromakalimDRUG

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

SalineDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Danish headache center

Glostrup Municipality, Denmark

Outcomes

Primary Outcomes

Headache

Occurrence of headache

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

Migraine

Occurrence of migraine

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

Aura

Occurrence of aura

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

Secondary Outcomes

The area under the curve (AUC) for headache

Headache intensity

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

Family history

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

Time frame: After including the patients in the study.

Heart rate

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

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

Blood pressure

Change in blood pressure measured in mmHg

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

Data from ClinicalTrials.gov

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