Headache Inducing Effect of Levcromakalim in Migraine With Aura Patients

February 28, 2020 updated by: Mohammad Al-Mahdi Al-Karagholi, Danish Headache Center
To investigate the role of KATP channels in migraine with aura patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

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, 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

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Saline
Drug: Saline
To investigate the role of levcromakalim compared with placebo in migraine with aura patients
Active Comparator: Levcromakalim
Drug: Levcromakalim
To investigate the role of levcromakalim compared with placebo in migraine with aura patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
Occurrence of migraine
Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
Aura
Time Frame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
Occurrence of aura
Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The area under the curve (AUC) for headache
Time Frame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
Headache intensity
Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
Family history
Time Frame: 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.
After including the patients in the study.
Heart rate
Time Frame: 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)
Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline
Blood pressure
Time Frame: 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
Before (-10 min) and after infusion (+2 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, Danish Headache Center

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)

July 9, 2019

Primary Completion (Actual)

December 10, 2019

Study Completion (Actual)

December 10, 2019

Study Registration Dates

First Submitted

July 4, 2019

First Submitted That Met QC Criteria

July 4, 2019

First Posted (Actual)

July 9, 2019

Study Record Updates

Last Update Posted (Actual)

March 2, 2020

Last Update Submitted That Met QC Criteria

February 28, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Journal-nr.: H-19023571

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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