Back to resultsHeadache Inducing Effect of Cromakalim in Migraine Patients
Primary Purpose
Headache, Migraine
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, Migraine focused on measuring Levcromakalim
Eligibility Criteria
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.
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
Cerebral hemodynamic
Change on Media cerebri arterie.
Headache
Occurrence of headache.
Migraine attack
Occurrence
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03228355
Brief Title
Headache Inducing Effect of Cromakalim in Migraine Patients
Official Title
The Effects of Levcromakalim on Cerebral Hemodynamic in Migraine Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
May 24, 2017 (Actual)
Primary Completion Date
November 30, 2017 (Actual)
Study Completion Date
November 30, 2017 (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 on the cerebral hemodynamic in migraine patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Migraine
Keywords
Levcromakalim
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (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 on cerebral hemodynamic in migraine patients
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
To investigate the role of levcromakalim compared with saline cerebral hemodynamic in migraine patients.
Primary Outcome Measure Information:
Title
Cerebral hemodynamic
Description
Change on Media cerebri arterie.
Time Frame
Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline
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 attack
Description
Occurrence
Time Frame
Before (-10 min) and after infusion (+12 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Messoud Ashina, Professor
Organizational Affiliation
DHC
Official's Role
Study Director
Facility Information:
Facility Name
Danish headache center
City
Copenhagen
State/Province
Glostrup
ZIP/Postal Code
2600
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31292608
Citation
Al-Karagholi MA, Hansen JM, Guo S, Olesen J, Ashina M. Opening of ATP-sensitive potassium channels causes migraine attacks: a new target for the treatment of migraine. Brain. 2019 Sep 1;142(9):2644-2654. doi: 10.1093/brain/awz199.
Results Reference
derived
Learn more about this trial
Headache Inducing Effect of Cromakalim in Migraine Patients
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