NCT04744129

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2020

Completed
7 months until next milestone

First Posted

Study publicly available on registry

February 8, 2021

Completed
1 year until next milestone

Study Start

First participant enrolled

February 25, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

February 13, 2023

Status Verified

February 1, 2023

Enrollment Period

11 months

First QC Date

July 21, 2020

Last Update Submit

February 10, 2023

Conditions

Headache, Migraine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in cerebral hemodynamic

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

  • Occurrence and change of headache

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

  • Change of diameter of the artery

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

Study Arms (2)

NN414

ACTIVE COMPARATOR

To investigate the role of NN414 compared with placebo in migraine patients.

Drug: NN414

Saline

PLACEBO COMPARATOR

To investigate the role of NN414 compared with placebo in migraine patients.

Drug: Saline

Interventions

NN414DRUG

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

Also known as: 6-Chloro-3-[[1-methylcyclopropyl]amino]-4H-thieno[3,2-e]-1,2,4-thiadiazine 1,1-dioxide
NN414
SalineDRUG

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

Saline

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Migraine patients of both sexes.
  • years.
  • kg.
  • Women of childbearing potential must use adequate contraception.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Headache Center

Copenhagen, Capital Region, 2600, Denmark

RECRUITING

Related Publications (1)

  • Kokoti L, Al-Karagholi MA, Zhuang ZA, Amirguliyev S, Amin FM, Ashina M. Non-vascular ATP-sensitive potassium channel activation does not trigger migraine attacks: A randomized clinical trial. Cephalalgia. 2024 May;44(5):3331024241248211. doi: 10.1177/03331024241248211.

    PMID: 38729773DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Quadruple
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD student, Principal investigator

Study Record Dates

First Submitted

July 21, 2020

First Posted

February 8, 2021

Study Start

February 25, 2022

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

February 13, 2023

Record last verified: 2023-02

Locations

DK(1)