Headache Inducing Effect of NN414 in Migraine Patients

February 10, 2023 updated by: Lili Kokoti, Danish Headache Center

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Capital Region
      • Copenhagen, Capital Region, Denmark, 2600
        • Recruiting
        • Danish Headache Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: NN414
To investigate the role of NN414 compared with placebo in migraine patients.
Drug: NN414
To investigate the role of NN414 on cerebral hemodynamic in migraine patients
Other Names:
  • 6-Chloro-3-[[1-methylcyclopropyl]amino]-4H-thieno[3,2-e]-1,2,4-thiadiazine 1,1-dioxide
PLACEBO_COMPARATOR: Saline
To investigate the role of NN414 compared with placebo in migraine patients.
Drug: Saline
To investigate the role of NN414 compared with saline cerebral hemodynamic in migraine patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence and change of migraine attack
Time Frame: 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
Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cerebral hemodynamic
Time Frame: 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.
Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline
Occurrence and change of headache
Time Frame: 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)
Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline
Change of diameter of the artery
Time Frame: 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).
Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Headache Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 25, 2022

Primary Completion (ANTICIPATED)

February 1, 2023

Study Completion (ANTICIPATED)

February 1, 2023

Study Registration Dates

First Submitted

July 21, 2020

First Submitted That Met QC Criteria

February 5, 2021

First Posted (ACTUAL)

February 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2023

Last Update Submitted That Met QC Criteria

February 10, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-20009266

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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