Status:
COMPLETED
Effect of Sumatriptan on Levcromakalim-Induced Symptoms in Individuals With Migraine
Lead Sponsor:
Danish Headache Center
Conditions:
Migraine Without Aura
Headache
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The study aims to explore the effects of Sumatriptan on Levcromakalim-induced migraine in individuals with migraine without aura.
Detailed 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...
Eligibility Criteria
Inclusion
- Participant has provided informed consent prior to initiation of any study-specific activities/procedures.
- Age ≥18 years upon entry into screening.
- History of migraine without aura for ≥12 months with a frequency of 1-5 migraine attacks per month before screening according to the International Headache Society (IHS) Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018), based on medical records and/or patient self-report.
Exclusion
- History of any primary headache disorder other than migraine without aura, or tension-type headache with a frequency of ≥5 headache days per month before screening according to the International Headache Society (IHS) Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018), based on medical records and/or patient self-report.
- History of any secondary headache disorder before screening according to the International Headache Society (IHS) Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018) based on medical records and/or patient self-report.
- Any headache 48 hours prior to, or any migraine 72 hours prior to the start of the experiment on day 1 and 2.
- Daily consumption of any drug/medication other than oral contraception (birth control).
- Intake of prophylactic migraine medication within ≤30 days or 5 plasma half-lives (whichever is longer) prior to screening.
- The participant is at risk of self-harm or harm to others as evidenced by past suicidal behavior.
- History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator will pose a risk to participant safety or interfere with the study evaluation, procedures or completion.
- Female participants of childbearing potential with a positive pregnancy test assessed at screening or day 1 by a urine pregnancy test.
- Female participants who are pregnant or breastfeeding or plan to become pregnant or breastfeed during participation in the study.
- Evidence of current pregnancy or breastfeeding per participant self-report or medical records.
- Participants likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participants' and investigator's knowledge.
Key Trial Info
Start Date :
March 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 5 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05211050
Start Date
March 15 2022
End Date
November 5 2023
Last Update
January 22 2025
Active Locations (1)
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1
Danish Headache Centre
Glostrup, Region Sjælland, Denmark, 2600