Migraine Clinical Trial
Official title:
Headache Inducing Effect of Levcromakalim in Migraine With Aura Patients
Verified date | February 2020 |
Source | Danish Headache Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To investigate the role of KATP channels in migraine with aura patients.
Status | Completed |
Enrollment | 17 |
Est. completion date | December 10, 2019 |
Est. primary completion date | December 10, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Danish headache center | Glostrup |
Lead Sponsor | Collaborator |
---|---|
Danish Headache Center |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Headache | Occurrence of headache | Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline | |
Primary | Migraine | Occurrence of migraine | Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline | |
Primary | Aura | Occurrence of aura | Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline | |
Secondary | The area under the curve (AUC) for headache | Headache intensity | Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline | |
Secondary | Family history | Direct interview with the 1 st degree family memeber for included patients according to international classification of headaches. | After including the patients in the study. | |
Secondary | Heart rate | Change in heart rate measured in Beats per minute (BPM) | Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline | |
Secondary | Blood pressure | Change in blood pressure measured in mmHg | Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline |
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