Aura, Headache, Migraine
Conditions
Keywords
Levcromakalim
Brief summary
To investigate the migraine inducing effect of levcromakalim in patients with migraine with aura.
Interventions
DRUGLevcromakalim
To investigate the role of levcromakalim compared with placebo in migraine with aura patients
DRUGSaline
To investigate the role of levcromakalim compared with placebo in migraine with aura patients
Sponsors
Danish Headache Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Headache incidence | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Headache intensity | 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 | 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 | 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 |
Countries
Denmark
Outcome results
None listed