Phase
Condition
Oral Facial Pain
Migraine (Pediatric)
Pain (Pediatric)
Treatment
Levcromakalim
Saline
Sumatriptan
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant has provided informed consent prior to initiation of any study-specificactivities/procedures.
Age ≥18 years upon entry into screening.
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:
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.
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.
Any headache 48 hours prior to, or any migraine 72 hours prior to the start of theexperiment on day 1 and 2.
Daily consumption of any drug/medication other than oral contraception (birthcontrol).
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 pastsuicidal behavior.
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.
Female participants of childbearing potential with a positive pregnancy testassessed at screening or day 1 by a urine pregnancy test.
Female participants who are pregnant or breastfeeding or plan to become pregnant orbreastfeed during participation in the study.
Evidence of current pregnancy or breastfeeding per participant self-report ormedical records.
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
Study Description
Connect with a study center
Danish Headache Centre
Glostrup, Zealand 2600
DenmarkSite Not Available
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