Headache Inducing Effect of Cromakalim in Migraine Patients

Headache, Migraine Clinical Trial

Official title:

The Effects of Levcromakalim on Cerebral Hemodynamic in Migraine Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03228355
• Other study ID #: Levcromakalim
• Status: Completed
• Phase: N/A
• Start date: May 24, 2017
• Est. completion date: November 30, 2017

Study information

• Verified date: June 2018
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the role of KATP channels on the cerebral hemodynamic in migraine patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 30, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Migraine patients of both sexes.

• 18-60 years.

• 50-90 kg.

• Women of childbearing potential must use adequate contraception.

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.

Related Conditions & MeSH terms

• Headache
• Headache, Migraine
• Migraine Disorders

Intervention

Drug:
• Levcromakalim
To investigate the role of Levcromakalim on cerebral hemodynamic in migraine patients
• Saline
To investigate the role of levcromakalim compared with saline cerebral hemodynamic in migraine patients.

Locations

Country	Name	City	State
Denmark	Danish headache center	Copenhagen	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	Cerebral hemodynamic	Change on Media cerebri arterie.	Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline
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 attack	Occurrence	Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline