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NCT04012047 Clinical Trial

Headache Inducing Effect of Levcromakalim in Migraine With Aura Patients

Migraine Clinical Trial

Official title:
Headache Inducing Effect of Levcromakalim in Migraine With Aura Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04012047
Other study ID # Journal-nr.: H-19023571
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 9, 2019
Est. completion date December 10, 2019

Study information
Verified date February 2020
Source Danish Headache Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 17
Est. completion date December 10, 2019
Est. primary completion date December 10, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Related Conditions & MeSH terms

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

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 Occurrence of headache Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
Primary Migraine Occurrence of migraine Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
Primary Aura Occurrence of aura Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
Secondary The area under the curve (AUC) for headache Headache intensity Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
Secondary Family history Direct interview with the 1 st degree family memeber for included patients according to international classification of headaches. After including the patients in the study.
Secondary Heart rate Change in heart rate measured in Beats per minute (BPM) Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline
Secondary Blood pressure Change in blood pressure measured in mmHg Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline
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