Effect of Sumatriptan on Levcromakalim-Induced Symptoms in Individuals With Migraine

Last updated: January 17, 2025
Sponsor: Danish Headache Center
Overall Status: Completed

Phase

N/A

Condition

Oral Facial Pain

Migraine (Pediatric)

Pain (Pediatric)

Treatment

Levcromakalim

Saline

Sumatriptan

Clinical Study ID

NCT05211050
H-21011542
  • Ages 18-65
  • All Genders

Study Summary

The study aims to explore the effects of Sumatriptan on Levcromakalim-induced migraine in individuals with migraine without aura.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participant has provided informed consent prior to initiation of any study-specificactivities/procedures.

  2. Age ≥18 years upon entry into screening.

  3. History of migraine without aura for ≥12 months with a frequency of 1-5 migraineattacks per month before screening according to the International Headache Society (IHS) Classification ICHD-3 (Headache Classification Committee of the InternationalHeadache Society, 2018), based on medical records and/or patient self-report.

Exclusion

Exclusion Criteria:

  1. History of any primary headache disorder other than migraine without aura, ortension-type headache with a frequency of ≥5 headache days per month beforescreening according to the International Headache Society (IHS) ClassificationICHD-3 (Headache Classification Committee of the International Headache Society, 2018), based on medical records and/or patient self-report.

  2. History of any secondary headache disorder before screening according to theInternational Headache Society (IHS) Classification ICHD-3 (Headache ClassificationCommittee of the International Headache Society, 2018) based on medical recordsand/or patient self-report.

  3. Any headache 48 hours prior to, or any migraine 72 hours prior to the start of theexperiment on day 1 and 2.

  4. Daily consumption of any drug/medication other than oral contraception (birthcontrol).

  5. Intake of prophylactic migraine medication within ≤30 days or 5 plasma half-lives (whichever is longer) prior to screening.

  6. The participant is at risk of self-harm or harm to others as evidenced by pastsuicidal behavior.

  7. History or evidence of any other clinically significant disorder, condition, ordisease (with the exception of those outlined above) that, in the opinion of theinvestigator will pose a risk to participant safety or interfere with the studyevaluation, procedures or completion.

  8. Female participants of childbearing potential with a positive pregnancy testassessed at screening or day 1 by a urine pregnancy test.

  9. Female participants who are pregnant or breastfeeding or plan to become pregnant orbreastfeed during participation in the study.

  10. Evidence of current pregnancy or breastfeeding per participant self-report ormedical records.

  11. Participants likely to not be available to complete all protocol-required studyvisits or procedures, and/or to comply with all required study procedures to thebest of the participants' and investigator's knowledge.

Study Design

Total Participants: 24
Treatment Group(s): 3
Primary Treatment: Levcromakalim
Phase:
Study Start date:
March 15, 2022
Estimated Completion Date:
November 05, 2023

Study Description

Opening of adenosine triphosphate-sensitive potassium (KATP) channels using Levcromakalim causes migraine attacks with and without aura in a high proportion of patients.

Sumatriptan has been shown to reverse Levcromakalim-induced dilation of the middle meningeal artery and headache in healthy volunteers, indicating that Sumatriptan can overturn the physiological effects of levcromakalim.

The study aims to explore the effects of Sumatriptan on Levcromakalim-induced migraine in individuals with migraine without aura.

Connect with a study center

  • Danish Headache Centre

    Glostrup, Zealand 2600
    Denmark

    Site Not Available

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