Headache Inducing Effect of Cromakalim in Migraine Patients
The Effects of Levcromakalim on Cerebral Hemodynamic in Migraine Patients
1 other identifier
interventional
16
1 country
1
Brief Summary
To investigate the role of KATP channels on the cerebral hemodynamic in migraine patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 24, 2017
CompletedFirst Submitted
Initial submission to the registry
July 8, 2017
CompletedFirst Posted
Study publicly available on registry
July 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2017
CompletedJune 19, 2018
June 1, 2018
6 months
July 8, 2017
June 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Cerebral hemodynamic
Change on Media cerebri arterie.
Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline
Headache
Occurrence of headache.
Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
Migraine attack
Occurrence
Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
Study Arms (2)
Levcromakalim
ACTIVE COMPARATORSaline
PLACEBO COMPARATORInterventions
To investigate the role of Levcromakalim on cerebral hemodynamic in migraine patients
To investigate the role of levcromakalim compared with saline cerebral hemodynamic in migraine patients.
Eligibility Criteria
You may qualify if:
- Migraine patients of both sexes.
- years.
- kg.
- Women of childbearing potential must use adequate contraception.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Danish headache center
Copenhagen, Glostrup, 2600, Denmark
Related Publications (1)
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.
PMID: 31292608DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Messoud Ashina, Professor
DHC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD student
Study Record Dates
First Submitted
July 8, 2017
First Posted
July 24, 2017
Study Start
May 24, 2017
Primary Completion
November 30, 2017
Study Completion
November 30, 2017
Last Updated
June 19, 2018
Record last verified: 2018-06