NCT04012047

Brief Summary

To investigate the role of KATP channels in migraine with aura patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 4, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

July 9, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2019

Completed
Last Updated

March 2, 2020

Status Verified

February 1, 2020

Enrollment Period

5 months

First QC Date

July 4, 2019

Last Update Submit

February 28, 2020

Conditions

HeadacheMigraineAura

Keywords

Levcromakalim

Outcome Measures

Primary Outcomes (3)

  • Headache

    Occurrence of headache

    Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline

  • Migraine

    Occurrence of migraine

    Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline

  • Aura

    Occurrence of aura

    Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline

Secondary Outcomes (4)

  • The area under the curve (AUC) for headache

    Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline

  • Family history

    After including the patients in the study.

  • Heart rate

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

  • Blood pressure

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

Study Arms (2)

Levcromakalim

ACTIVE COMPARATOR
Drug: Levcromakalim

Saline

PLACEBO COMPARATOR
Drug: Saline

Interventions

LevcromakalimDRUG

To investigate the role of levcromakalim compared with placebo in migraine with aura patients

Levcromakalim
SalineDRUG

To investigate the role of levcromakalim compared with placebo in migraine with aura patients

Saline

Eligibility Criteria

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

You may qualify if:

  • Migraine with aura patients of both sexes.
  • years.
  • kg.

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish headache center

Glostrup Municipality, 2600, Denmark

Location

Related Publications (1)

  • Al-Karagholi MA, Ghanizada H, Nielsen CAW, Hougaard A, Ashina M. Opening of ATP sensitive potassium channels causes migraine attacks with aura. Brain. 2021 Sep 4;144(8):2322-2332. doi: 10.1093/brain/awab136.

    PMID: 33768245DERIVED

MeSH Terms

Conditions

HeadacheMigraine DisordersEpilepsy

Interventions

CromakalimSodium Chloride

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzopyransPyransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Messoud Ashina

    Danish Headache Center

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

July 4, 2019

First Posted

July 9, 2019

Study Start

July 9, 2019

Primary Completion

December 10, 2019

Study Completion

December 10, 2019

Last Updated

March 2, 2020

Record last verified: 2020-02

Locations

DK(1)