Migraine Inducing Effect of Levcromakalim in Patients With Migraine With Aura

May 16, 2023 updated by: Andreas Vinther Thomsen, Danish Headache Center
To investigate the migraine inducing effect of levcromakalim in patients with migraine with aura.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

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
    • Copenhagen
      • Glostrup, Copenhagen, Denmark, DK-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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Migraine with aura patients of both sexes.
  • 18-70 years.
  • 50-100 kg.

Exclusion Criteria:

  • Headache less than 48 hours before the tests start
  • Daily consumption of drugs of any kind that investigator deems might affect study results or safety.
  • Pregnant or nursing women.
  • Cardiovascular disease of any kind, including cerebrovascular diseases.
  • Tension type headache (TTH) according to International Classification of Headache Disorders version 3 more than 5 times a month on average during the past year
  • Known cluster headache according to International Classification of Headache Disorders version 3.
  • Psychiatric disorder
  • Smoking or abuse of drugs or alcohol
  • Hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg) on day of inclusion.
  • Hypotension (systolic blood pressure <90 mmHg and/or diastolic blood pressure <50 mmHg) on day of inclusion.

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 incidence
Time Frame: 10 minutes before until 24 hours after infusion of levcromakalim or placebo
Difference in incidence of headache following infusion of levcromakalim compared to placebo in patients with migraine with aura.
10 minutes before until 24 hours after infusion of levcromakalim or placebo
Migraine incidence
Time Frame: 10 minutes before until 24 hours after infusion of levcromakalim or placebo
Difference in incidence of migraine-like headache following infusion of levcromakalim compared to placebo in patients with migraine with aura.
10 minutes before until 24 hours after infusion of levcromakalim or placebo
Aura incidence
Time Frame: 10 minutes before until 24 hours after infusion of levcromakalim or placebo
Difference in incidence of migraine aura following infusion of levcromakalim compared to placebo in patients with migraine with aura.
10 minutes before until 24 hours after infusion of levcromakalim or placebo

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Headache intensity
Time Frame: 10 minutes before until 24 hours after infusion of levcromakalim or placebo
The area under the curve (AUC) for headache following infusion of levcromakalim compared to placebo in patients with migraine with aura
10 minutes before until 24 hours after infusion of levcromakalim or placebo
Heart rate
Time Frame: 10 minutes before until 120 minutes after infusion of levcromakalim or placebo
Change in heart rate measured in Beats per minute (BPM) following infusion of levcromakalim compared to placebo in patients with migraine with aura
10 minutes before until 120 minutes after infusion of levcromakalim or placebo
Blood pressure
Time Frame: 10 minutes before until 120 minutes after infusion of levcromakalim or placebo
Change in blood pressure (systolic and diastolic) measured in mmHg following infusion of levcromakalim compared to placebo in patients with migraine with aura
10 minutes before until 120 minutes after infusion of levcromakalim or placebo

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

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)

September 29, 2021

Primary Completion (Actual)

May 16, 2023

Study Completion (Actual)

May 16, 2023

Study Registration Dates

First Submitted

May 21, 2021

First Submitted That Met QC Criteria

May 25, 2021

First Posted (Actual)

May 27, 2021

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 16, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-20049785

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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