Headache Inducing Effect of Levcromakalim in Migraine With Aura Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04012047

Enrollment

Registered

2019-07-09

Start date

2019-07-09

Completion date

2019-12-10

Last updated

2020-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aura, Headache, Migraine

Keywords

Levcromakalim

Brief summary

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

Interventions

DRUGLevcromakalim

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

DRUGSaline

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Migraine with aura patients of both sexes. * 18-60 years. * 50-100 kg.

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.

Design outcomes

Primary

Measure	Time frame	Description
Headache	Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline	Occurrence of headache
Migraine	Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline	Occurrence of migraine
Aura	Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline	Occurrence of aura

Secondary

Measure	Time frame	Description
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	Headache intensity
Blood pressure	Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline	Change in blood pressure measured in mmHg
Family history	After including the patients in the study.	Direct interview with the 1 st degree family memeber for included patients according to international classification of headaches.
Heart rate	Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline	Change in heart rate measured in Beats per minute (BPM)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026