search
Back to results

Migraine Inducing Effect of Levcromakalim in Patients With Migraine With Aura

Primary Purpose

Headache, Migraine, Aura

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Levcromakalim
Saline
Sponsored by
Danish Headache Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Headache, Migraine focused on measuring Levcromakalim

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Danish Headache Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Levcromakalim

Saline

Arm Description

Outcomes

Primary Outcome Measures

Headache incidence
Difference in incidence of headache following infusion of levcromakalim compared to placebo in patients with migraine with aura.
Migraine incidence
Difference in incidence of migraine-like headache following infusion of levcromakalim compared to placebo in patients with migraine with aura.
Aura incidence
Difference in incidence of migraine aura following infusion of levcromakalim compared to placebo in patients with migraine with aura.

Secondary Outcome Measures

Headache intensity
The area under the curve (AUC) for headache following infusion of levcromakalim compared to placebo in patients with migraine with aura
Heart rate
Change in heart rate measured in Beats per minute (BPM) following infusion of levcromakalim compared to placebo in patients with migraine with aura
Blood pressure
Change in blood pressure (systolic and diastolic) measured in mmHg following infusion of levcromakalim compared to placebo in patients with migraine with aura

Full Information

First Posted
May 21, 2021
Last Updated
May 16, 2023
Sponsor
Danish Headache Center
search

1. Study Identification

Unique Protocol Identification Number
NCT04905654
Brief Title
Migraine Inducing Effect of Levcromakalim in Patients With Migraine With Aura
Official Title
Migraine Inducing Effect of Levcromakalim in Patients With Migraine With Aura
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 29, 2021 (Actual)
Primary Completion Date
May 16, 2023 (Actual)
Study Completion Date
May 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Headache Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To investigate the migraine inducing effect of levcromakalim in patients with migraine with aura.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Migraine, Aura
Keywords
Levcromakalim

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levcromakalim
Arm Type
Active Comparator
Arm Title
Saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Levcromakalim
Intervention Description
To investigate the role of levcromakalim compared with placebo in migraine with aura patients
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
To investigate the role of levcromakalim compared with placebo in migraine with aura patients
Primary Outcome Measure Information:
Title
Headache incidence
Description
Difference in incidence of headache following infusion of levcromakalim compared to placebo in patients with migraine with aura.
Time Frame
10 minutes before until 24 hours after infusion of levcromakalim or placebo
Title
Migraine incidence
Description
Difference in incidence of migraine-like headache following infusion of levcromakalim compared to placebo in patients with migraine with aura.
Time Frame
10 minutes before until 24 hours after infusion of levcromakalim or placebo
Title
Aura incidence
Description
Difference in incidence of migraine aura following infusion of levcromakalim compared to placebo in patients with migraine with aura.
Time Frame
10 minutes before until 24 hours after infusion of levcromakalim or placebo
Secondary Outcome Measure Information:
Title
Headache intensity
Description
The area under the curve (AUC) for headache following infusion of levcromakalim compared to placebo in patients with migraine with aura
Time Frame
10 minutes before until 24 hours after infusion of levcromakalim or placebo
Title
Heart rate
Description
Change in heart rate measured in Beats per minute (BPM) following infusion of levcromakalim compared to placebo in patients with migraine with aura
Time Frame
10 minutes before until 120 minutes after infusion of levcromakalim or placebo
Title
Blood pressure
Description
Change in blood pressure (systolic and diastolic) measured in mmHg following infusion of levcromakalim compared to placebo in patients with migraine with aura
Time Frame
10 minutes before until 120 minutes after infusion of levcromakalim or placebo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Messoud Ashina
Organizational Affiliation
Danish Headache Center
Official's Role
Study Director
Facility Information:
Facility Name
Danish Headache Center
City
Glostrup
State/Province
Copenhagen
ZIP/Postal Code
DK-2600
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Migraine Inducing Effect of Levcromakalim in Patients With Migraine With Aura

We'll reach out to this number within 24 hrs