Headache Inducing Effect of Levcromakalim in Migraine With Aura Patients

Overview

To investigate the role of KATP channels in migraine with aura patients.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 10, 2019

Interventions

  • Drug: Levcromakalim
    • To investigate the role of levcromakalim compared with placebo in migraine with aura patients
  • Drug: Saline
    • To investigate the role of levcromakalim compared with placebo in migraine with aura patients

Arms, Groups and Cohorts

  • Active Comparator: Levcromakalim
  • Placebo Comparator: Saline

Clinical Trial Outcome Measures

Primary Measures

  • 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
    • Time Frame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
    • Occurrence of migraine
  • Aura
    • Time Frame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
    • Occurrence of aura

Secondary Measures

  • The area under the curve (AUC) for headache
    • Time Frame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
    • Headache intensity
  • Family history
    • Time Frame: After including the patients in the study.
    • Direct interview with the 1 st degree family memeber for included patients according to international classification of headaches.
  • Heart rate
    • Time Frame: Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline
    • Change in heart rate measured in Beats per minute (BPM)
  • Blood pressure
    • Time Frame: Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline
    • Change in blood pressure measured in mmHg

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Danish Headache Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mohammad Al-Mahdi Al-Karagholi, MD, PhD student – Danish Headache Center
  • Overall Official(s)
    • Messoud Ashina, Study Director, Danish Headache Center

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