Headache Inducing Effect of Levcromakalim in Migraine With Aura Patients

Not Applicable

Completed

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

• Registration Number: NCT04012047
• Lead Sponsor: Danish Headache Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-04
• Study First Submitted QC: 2019-07-04
• Study Start: 2019-07-09
• Study First Posted: 2019-07-09
• Primary Completion: 2019-12-10
• Study Completion: 2019-12-10
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-28
• Last Update Posted: 2020-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Levcromakalim	Levcromakalim	-
Saline	Saline	-

Primary Outcome Measures

Name	Time	Method
Headache	Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline	Occurrence of headache
Migraine	Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline	Occurrence of migraine
Aura	Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline	Occurrence of aura

Secondary Outcome Measures

Name	Time	Method
The area under the curve (AUC) for headache	Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline	Headache intensity
Family history	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.
Heart rate	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)
Blood pressure	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

Trial Locations

Locations (1)

Danish headache center; 🇩🇰 Glostrup, Denmark