Back to resultsHeadache Inducing Effect of Levcromakalim in Migraine With Aura Patients
Primary Purpose
Headache, Migraine, Aura
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Levcromakalim
Saline
Sponsored by
About this trial
This is an interventional other trial for Headache focused on measuring Levcromakalim
Eligibility Criteria
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.
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
Occurrence of headache
Migraine
Occurrence of migraine
Aura
Occurrence of aura
Secondary Outcome Measures
The area under the curve (AUC) for headache
Headache intensity
Family history
Direct interview with the 1 st degree family memeber for included patients according to international classification of headaches.
Heart rate
Change in heart rate measured in Beats per minute (BPM)
Blood pressure
Change in blood pressure measured in mmHg
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04012047
Brief Title
Headache Inducing Effect of Levcromakalim in Migraine With Aura Patients
Official Title
Headache Inducing Effect of Levcromakalim in Migraine With Aura Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 9, 2019 (Actual)
Primary Completion Date
December 10, 2019 (Actual)
Study Completion Date
December 10, 2019 (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 role of KATP channels in migraine with aura patients.
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
17 (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
Description
Occurrence of headache
Time Frame
Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
Title
Migraine
Description
Occurrence of migraine
Time Frame
Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
Title
Aura
Description
Occurrence of aura
Time Frame
Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
Secondary Outcome Measure Information:
Title
The area under the curve (AUC) for headache
Description
Headache intensity
Time Frame
Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
Title
Family history
Description
Direct interview with the 1 st degree family memeber for included patients according to international classification of headaches.
Time Frame
After including the patients in the study.
Title
Heart rate
Description
Change in heart rate measured in Beats per minute (BPM)
Time Frame
Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline
Title
Blood pressure
Description
Change in blood pressure measured in mmHg
Time Frame
Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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
ZIP/Postal Code
2600
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33768245
Citation
Al-Karagholi MA, Ghanizada H, Nielsen CAW, Hougaard A, Ashina M. Opening of ATP sensitive potassium channels causes migraine attacks with aura. Brain. 2021 Sep 4;144(8):2322-2332. doi: 10.1093/brain/awab136.
Results Reference
derived
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Headache Inducing Effect of Levcromakalim in Migraine With Aura Patients
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