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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