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CompletedNCT04905654Updated May 17, 2023

Migraine Inducing Effect of Levcromakalim in Patients With Migraine With Aura

An interventional study of Levcromakalim and Saline in Headache, Migraine and Aura, sponsored by Danish Headache Center. Completed at 1 site in Denmark. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-05-17.

Sponsored by Danish Headache Center · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Headache, Migraine
  • Aura

Keywords

  • Levcromakalim
03

In context

Migraine Disorders

1,558 studies on the registry are indexed under Migraine Disorders; 301 are open to participants now.

This study's enrollment of 35 is below the median of 80 across 1,197 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Danish Headache Center is the lead sponsor of 129 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Migraine with aura patients of both sexes.
  • 18-70 years.
  • 50-100 kg.

Exclusion criteria

Exclusion Criteria:

  • 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
  • Hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg) on day of inclusion.
  • Hypotension (systolic blood pressure \<90 mmHg and/or diastolic blood pressure \<50 mmHg) on day of inclusion.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
35 participants (actual)

Study arms

  • Active comparator
    Levcromakalim

    Drug: Levcromakalim

  • Placebo comparator
    Saline

    Drug: Saline

Interventions

  • 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

06

What researchers measure

Primary outcomes

  1. Headache incidence

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

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

  2. Migraine incidence

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

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

  3. Aura incidence

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

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

Secondary outcomes

  1. Headache intensity

    The area under the curve (AUC) for headache following infusion of levcromakalim compared to placebo in patients with migraine with aura

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

  2. Heart rate

    Change in heart rate measured in Beats per minute (BPM) following infusion of levcromakalim compared to placebo in patients with migraine with aura

    Time frame: 10 minutes before until 120 minutes after infusion of levcromakalim or placebo

  3. Blood pressure

    Change in blood pressure (systolic and diastolic) measured in mmHg following infusion of levcromakalim compared to placebo in patients with migraine with aura

    Time frame: 10 minutes before until 120 minutes after infusion of levcromakalim or placebo

07

Study locations

1 site
  • Danish Headache Center
    Glostrup Municipality, Copenhagen DK-2600, Denmark
08

References and documents

Publications

  • 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. PubMed 39161224 ↗
  • 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. PubMed 38501895 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04905654
Responsible party
Andreas Vinther Thomsen (Principal Investigator, Danish Headache Center) — Principal investigator
First posted
May 27, 2021
Start date
Sep 29, 2021
Primary completion
May 16, 2023
Completion
May 16, 2023
Last update
May 17, 2023

Study contacts

Messoud Ashina
study director · Danish Headache Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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