Headache Inducing Effect of NN414 in Migraine Patients

Not Applicable

Recruiting

• Conditions: Headache, Migraine
• Interventions: Drug: NN414; Drug: Saline

• Registration Number: NCT04744129
• Lead Sponsor: Danish Headache Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-21
• Study First Submitted QC: 2021-02-05
• Study First Posted: 2021-02-08
• Study Start: 2022-02-25
• Status Verified: 2023-02
• Primary Completion: 2023-02
• Study Completion: 2023-02
• Last Update Submitted: 2023-02-10
• Last Update Posted: 2023-02-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NN414	NN414	To investigate the role of NN414 compared with placebo in migraine patients.
Saline	Saline	To investigate the role of NN414 compared with placebo in migraine patients.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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.
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).

Trial Locations

Locations (1)

Danish Headache Center; 🇩🇰 Copenhagen, Capital Region, Denmark