Headache Inducing Effect of NN414 in Migraine Patients

Headache, Migraine Clinical Trial

Official title:

NN414's Effect in Cerebral Hemodynamics and Headache Induction in Migraine Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04744129
• Other study ID #: H-20009266
• Status: Recruiting
• Phase: N/A
• Start date: February 25, 2022
• Est. completion date: February 2023

Study information

• Verified date: February 2023
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: February 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Headache, Migraine
• Migraine Disorders

Intervention

Drug:
• NN414
To investigate the role of NN414 on cerebral hemodynamic in migraine patients
• Saline
To investigate the role of NN414 compared with saline cerebral hemodynamic in migraine patients.

Locations

Country	Name	City	State
Denmark	Danish Headache Center	Copenhagen	Capital Region

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence and change of migraine attack	Occurrence of migraine according to international criteria	Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline
Secondary	Change in cerebral hemodynamic	Change on velocity of media cerebri artery.	Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline
Secondary	Occurrence and change of headache	Occurrence of headache measured by numerical rating scale (NRS)	Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline
Secondary	Change of diameter of the artery	Change of diameter of superficial temporal artery and radial artery. The diameter will be measured by millimeter (mm).	Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline