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Headache Inducing Effect of Cromakalim in Migraine Patients

NCT03228355 — Not applicable, Completed, 16 participants, Danish Headache Center
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The Effects of Levcromakalim on Cerebral Hemodynamic in Migraine Patients

RegistryNCT03228355
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, crossover, masking: quadruple, other
Enrollment16 (Actual)
SponsorDanish Headache Center (Other)
ConditionsHeadache, Migraine
InterventionsLevcromakalim, Saline (Drug)
Datesstart 2017-05-24, primary completion 2017-11-30, completion 2017-11-30, first posted 2017-07-24, last updated 2018-06-19
Locations1 site in Denmark

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-Summary

To investigate the role of KATP channels on the cerebral hemodynamic in migraine patients.

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+Arms and interventions

ArmTypeInterventionsDescription
LevcromakalimActive comparatorDrug: Levcromakalim
SalinePlacebo comparatorDrug: Saline
  • Levcromakalim (Drug): To investigate the role of Levcromakalim on cerebral hemodynamic in migraine patients
  • Saline (Drug): To investigate the role of levcromakalim compared with saline cerebral hemodynamic in migraine patients.

+Outcome measures

Primary outcomes

  • Cerebral hemodynamic [Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline]: Change on Media cerebri arterie.
  • Headache [Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline]: Occurrence of headache.
  • Migraine attack [Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline]: Occurrence

+Eligibility

Sex: All, ages: 18 Years to 60 Years

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.

+Locations (1)

FacilityCityCountryStatus
Danish headache centerCopenhagen, GlostrupDenmark

+Publications

  • Results publication: 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 31292608

+Investigators

My Notes