Migraine Inducing Effect of Levcromakalim in Patients With Migraine With Aura

Overview

To investigate the migraine inducing effect of levcromakalim in patients with migraine with aura.

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: May 16, 2023

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 incidence
    • Time Frame: 10 minutes before until 24 hours after infusion of levcromakalim or placebo
    • Difference in incidence of headache following infusion of levcromakalim compared to placebo in patients with migraine with aura.
  • Migraine incidence
    • Time Frame: 10 minutes before until 24 hours after infusion of levcromakalim or placebo
    • Difference in incidence of migraine-like headache following infusion of levcromakalim compared to placebo in patients with migraine with aura.
  • Aura incidence
    • Time Frame: 10 minutes before until 24 hours after infusion of levcromakalim or placebo
    • Difference in incidence of migraine aura following infusion of levcromakalim compared to placebo in patients with migraine with aura.

Secondary Measures

  • Headache intensity
    • Time Frame: 10 minutes before until 24 hours after infusion of levcromakalim or placebo
    • The area under the curve (AUC) for headache following infusion of levcromakalim compared to placebo in patients with migraine with aura
  • Heart rate
    • Time Frame: 10 minutes before until 120 minutes after infusion of levcromakalim or placebo
    • Change in heart rate measured in Beats per minute (BPM) following infusion of levcromakalim compared to placebo in patients with migraine with aura
  • Blood pressure
    • Time Frame: 10 minutes before until 120 minutes after infusion of levcromakalim or placebo
    • Change in blood pressure (systolic and diastolic) measured in mmHg following infusion of levcromakalim compared to placebo in patients with migraine with aura

Participating in This Clinical Trial

Inclusion Criteria

  • Migraine with aura patients of both sexes. – 18-70 years. – 50-100 kg. Exclusion Criteria:

  • Headache less than 48 hours before the tests start – Daily consumption of drugs of any kind that investigator deems might affect study results or safety. – Pregnant or nursing women. – Cardiovascular disease of any kind, including cerebrovascular diseases. – Tension type headache (TTH) according to International Classification of Headache Disorders version 3 more than 5 times a month on average during the past year – Known cluster headache according to International Classification of Headache Disorders version 3. – Psychiatric disorder – Smoking or abuse of drugs or alcohol – Hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg) on day of inclusion. – Hypotension (systolic blood pressure <90 mmHg and/or diastolic blood pressure <50 mmHg) on day of inclusion.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Danish Headache Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Andreas Vinther Thomsen, Principal Investigator – Danish Headache Center
  • Overall Official(s)
    • Messoud Ashina, Study Director, Danish Headache Center

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