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Headache Inducing Effect of Cromakalim in Migraine Patients

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ClinicalTrials.gov Identifier: NCT03228355
Recruitment Status : Completed
First Posted : July 24, 2017
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Mohammad Al-Mahdi Al-Karagholi, Danish Headache Center

July 8, 2017
July 24, 2017
June 19, 2018
May 24, 2017
November 30, 2017   (Final data collection date for primary outcome measure)
  • Cerebral hemodynamic [ Time Frame: Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline ]
    Change on Media cerebri arterie.
  • Headache [ Time Frame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline ]
    Occurrence of headache.
  • Migraine attack [ Time Frame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline ]
    Occurrence
  • Cerebral hemodynamic [ Time Frame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline ]
    Change on Media cerebri arterie.
  • Headache [ Time Frame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline ]
    Occurrence of headache.
  • Migraine attack [ Time Frame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline ]
    Occurrence
Complete list of historical versions of study NCT03228355 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Headache Inducing Effect of Cromakalim in Migraine Patients
The Effects of Levcromakalim on Cerebral Hemodynamic in Migraine Patients
To investigate the role of KATP channels on the cerebral hemodynamic in migraine patients.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Headache, Migraine
  • Drug: Levcromakalim
    To investigate the role of Levcromakalim on cerebral hemodynamic in migraine patients
  • Drug: Saline
    To investigate the role of levcromakalim compared with saline cerebral hemodynamic in migraine patients.
  • Active Comparator: Levcromakalim
    Intervention: Drug: Levcromakalim
  • Placebo Comparator: Saline
    Intervention: Drug: Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
12
November 30, 2017
November 30, 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT03228355
Levcromakalim
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Mohammad Al-Mahdi Al-Karagholi, Danish Headache Center
Danish Headache Center
Not Provided
Study Director: Messoud Ashina, Professor DHC
Danish Headache Center
June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP