Headache Inducing Effect of Cromakalim in Migraine Patients

Not Applicable

Completed

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

• Registration Number: NCT03228355
• Lead Sponsor: Danish Headache Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-24
• Study First Submitted: 2017-07-08
• Study First Submitted QC: 2017-07-21
• Study First Posted: 2017-07-24
• Primary Completion: 2017-11-30
• Study Completion: 2017-11-30
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-18
• Last Update Posted: 2018-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Saline	Saline	-
Levcromakalim	Levcromakalim	-

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.
Cerebral hemodynamic	Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline	Change on Media cerebri arterie.
Migraine attack	Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline	Occurrence

Trial Locations

Locations (1)

Danish headache center; 🇩🇰 Copenhagen, Glostrup, Denmark