Migraine Inducing Effect of Levcromakalim in Patients With Migraine With Aura

Danish Headache Center

Status: Completed

Conditions: Headache, Migraine; Aura

Treatments: Drug: Levcromakalim; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04905654

H-20049785

Details and patient eligibility

About

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

Enrollment: 35 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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35 participants in 2 patient groups, including a placebo group

Levcromakalim

Active Comparator group

Treatment:

Drug: Levcromakalim

Saline

Placebo Comparator group

Treatment:

Drug: Saline