Migraine Inducing Effect of Levcromakalim in Patients With Migraine With Aura

Not Applicable

Completed

• Conditions: Headache, Migraine; Aura
• Interventions: Drug: Saline; Drug: Levcromakalim

• Registration Number: NCT04905654
• Lead Sponsor: Danish Headache Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-21
• Study First Submitted QC: 2021-05-25
• Study First Posted: 2021-05-27
• Study Start: 2021-09-29
• Status Verified: 2023-05
• Primary Completion: 2023-05-16
• Study Completion: 2023-05-16
• Last Update Submitted: 2023-05-16
• Last Update Posted: 2023-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Saline	Saline	-
Levcromakalim	Levcromakalim	-

Primary Outcome Measures

Name	Time	Method
Headache incidence	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.
Aura incidence	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.
Migraine incidence	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.

Secondary Outcome Measures

Name	Time	Method
Heart rate	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
Blood pressure	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
Headache intensity	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

Trial Locations

Locations (1)

Danish Headache Center; 🇩🇰 Glostrup, Copenhagen, Denmark