Headache, Migraine
Conditions
Brief summary
To investigate the role of KATP channels on the cerebral hemodynamic in migraine patients.
Interventions
DRUGSaline
To investigate the role of NN414 compared with saline cerebral hemodynamic in migraine patients.
DRUGNN414
To investigate the role of NN414 on cerebral hemodynamic in migraine patients
Sponsors
Danish Headache Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Quadruple
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Criteria Inclusion Criteria: * Migraine patients of both sexes. * 18-60 years. * 50-100 kg. * Women of childbearing potential must use adequate contraception.
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. * Diabetes mellitus and other endocrinologic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence and change of migraine attack | Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline | Occurrence of migraine according to international criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in cerebral hemodynamic | Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline | Change on velocity of media cerebri artery. |
| Occurrence and change of headache | Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline | Occurrence of headache measured by numerical rating scale (NRS) |
| Change of diameter of the artery | Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline | Change of diameter of superficial temporal artery and radial artery. The diameter will be measured by millimeter (mm). |
Countries
Denmark
Outcome results
None listed