Headache Inducing Effect of Cromakalim in Migraine Patients

June 18, 2018 updated by: Mohammad Al-Mahdi Al-Karagholi, Danish Headache Center

The Effects of Levcromakalim on Cerebral Hemodynamic in Migraine Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Glostrup
      • Copenhagen, Glostrup, Denmark, 2600
        • Danish Headache Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Saline
Drug: Saline
To investigate the role of levcromakalim compared with saline cerebral hemodynamic in migraine patients.
ACTIVE_COMPARATOR: Levcromakalim
Drug: Levcromakalim
To investigate the role of Levcromakalim on cerebral hemodynamic in migraine patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral hemodynamic
Time Frame: Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline
Change on Media cerebri arterie.
Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline
Headache
Time Frame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
Occurrence of headache.
Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
Migraine attack
Time Frame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
Occurrence
Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Headache Center

Investigators

  • Study Director: Messoud Ashina, Professor, DHC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 24, 2017

Primary Completion (ACTUAL)

November 30, 2017

Study Completion (ACTUAL)

November 30, 2017

Study Registration Dates

First Submitted

July 8, 2017

First Submitted That Met QC Criteria

July 21, 2017

First Posted (ACTUAL)

July 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 19, 2018

Last Update Submitted That Met QC Criteria

June 18, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Levcromakalim

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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