Migraine Inducing Effect of Levcromakalim in Patients With Migraine With Aura

Headache, Migraine Clinical Trial

Official title:

Migraine Inducing Effect of Levcromakalim in Patients With Migraine With Aura

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04905654
• Other study ID #: H-20049785
• Status: Completed
• Phase: N/A
• Start date: September 29, 2021
• Est. completion date: May 16, 2023

Study information

• Verified date: May 2023
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 16, 2023
• Est. primary completion date: May 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aura
• Headache
• Headache, Migraine
• Migraine Disorders
• Migraine with Aura

Intervention

Drug:
• Levcromakalim
To investigate the role of levcromakalim compared with placebo in migraine with aura patients
• Saline
To investigate the role of levcromakalim compared with placebo in migraine with aura patients

Locations

Country	Name	City	State
Denmark	Danish Headache Center	Glostrup	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache incidence	Difference in incidence of headache following infusion of levcromakalim compared to placebo in patients with migraine with aura.	10 minutes before until 24 hours after infusion of levcromakalim or placebo
Primary	Migraine incidence	Difference in incidence of migraine-like headache following infusion of levcromakalim compared to placebo in patients with migraine with aura.	10 minutes before until 24 hours after infusion of levcromakalim or placebo
Primary	Aura incidence	Difference in incidence of migraine aura following infusion of levcromakalim compared to placebo in patients with migraine with aura.	10 minutes before until 24 hours after infusion of levcromakalim or placebo
Secondary	Headache intensity	The area under the curve (AUC) for headache following infusion of levcromakalim compared to placebo in patients with migraine with aura	10 minutes before until 24 hours after infusion of levcromakalim or placebo
Secondary	Heart rate	Change in heart rate measured in Beats per minute (BPM) following infusion of levcromakalim compared to placebo in patients with migraine with aura	10 minutes before until 120 minutes after infusion of levcromakalim or placebo
Secondary	Blood pressure	Change in blood pressure (systolic and diastolic) measured in mmHg following infusion of levcromakalim compared to placebo in patients with migraine with aura	10 minutes before until 120 minutes after infusion of levcromakalim or placebo