NCT04905654

Brief Summary

To investigate the migraine inducing effect of levcromakalim in patients with migraine with aura.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

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

May 21, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 27, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

September 29, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2023

Completed
Last Updated

May 17, 2023

Status Verified

May 1, 2023

Enrollment Period

1.6 years

First QC Date

May 21, 2021

Last Update Submit

May 16, 2023

Conditions

Headache, MigraineAura

Keywords

Levcromakalim

Outcome Measures

Primary Outcomes (3)

  • Headache incidence

    Difference in incidence of headache following infusion of levcromakalim compared to placebo in patients with migraine with aura.

    10 minutes before until 24 hours after infusion of levcromakalim or placebo

  • Migraine incidence

    Difference in incidence of migraine-like headache following infusion of levcromakalim compared to placebo in patients with migraine with aura.

    10 minutes before until 24 hours after infusion of levcromakalim or placebo

  • Aura incidence

    Difference in incidence of migraine aura following infusion of levcromakalim compared to placebo in patients with migraine with aura.

    10 minutes before until 24 hours after infusion of levcromakalim or placebo

Secondary Outcomes (3)

  • Headache intensity

    10 minutes before until 24 hours after infusion of levcromakalim or placebo

  • Heart rate

    10 minutes before until 120 minutes after infusion of levcromakalim or placebo

  • Blood pressure

    10 minutes before until 120 minutes after infusion of levcromakalim or placebo

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 - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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 that investigator deems might affect study results or safety.
  • Pregnant or nursing women.
  • Cardiovascular disease of any kind, including cerebrovascular diseases.
  • Tension type headache (TTH) according to International Classification of Headache Disorders version 3 more than 5 times a month on average during the past year
  • Known cluster headache according to International Classification of Headache Disorders version 3.
  • Psychiatric disorder
  • Smoking or abuse of drugs or alcohol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Headache Center

Glostrup Municipality, Copenhagen, DK-2600, Denmark

Location

Related Publications (2)

  • Thomsen AV, Al-Karagholi MA, Hougaard A, Ostrowski SR, Ashina M. Effects of levcromakalim in patients with migraine aura without headache: An experimental study. Cephalalgia. 2024 Aug;44(8):3331024241274366. doi: 10.1177/03331024241274366.

    PMID: 39161224DERIVED

  • Thomsen AV, Al-Karagholi MA, Hougaard A, Ostrowski SR, Pedersen OB, Hansen TF, Ashina M. Investigations of the migraine-provoking effect of levcromakalim in patients with migraine with aura. Cephalalgia. 2024 Mar;44(3):3331024241237247. doi: 10.1177/03331024241237247.

    PMID: 38501895DERIVED

MeSH Terms

Conditions

Migraine DisordersEpilepsy

Interventions

CromakalimSodium Chloride

Condition Hierarchy (Ancestors)

Headache 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
Principal Investigator

Study Record Dates

First Submitted

May 21, 2021

First Posted

May 27, 2021

Study Start

September 29, 2021

Primary Completion

May 16, 2023

Study Completion

May 16, 2023

Last Updated

May 17, 2023

Record last verified: 2023-05

Locations

DK(1)