Headache Inducing Effect of NN414 in Migraine Patients

N/AUnknownNCT04744129

Danish Headache Center16 enrolled

Overview

To investigate the role of KATP channels on the cerebral hemodynamic in migraine patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Headache, Migraine

Interventions

NN414DRUG

To investigate the role of NN414 on cerebral hemodynamic in migraine patients

SalineDRUG

To investigate the role of NN414 compared with saline cerebral hemodynamic in migraine patients.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Danish Headache Center

Copenhagen, Capital Region, Denmark

RECRUITING

Outcomes

Primary Outcomes

Occurrence and change of migraine attack

Occurrence of migraine according to international criteria

Time frame: Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline

Secondary Outcomes

Change in cerebral hemodynamic

Change on velocity of media cerebri artery.

Time frame: Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline

Occurrence and change of headache

Occurrence of headache measured by numerical rating scale (NRS)

Time frame: Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline

Change of diameter of the artery

Change of diameter of superficial temporal artery and radial artery. The diameter will be measured by millimeter (mm).

Time frame: Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline

Data from ClinicalTrials.gov

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