NCT05211050Completed
Effect of Sumatriptan on Levcromakalim-Induced Symptoms in Individuals With Migraine
Effect of Sumatriptan on Levcromakalim-Induced Symptoms in Individuals With Migraine: A Randomized Double-Blind Two-Way Crossover Study
Source: ClinicalTrials.gov · Last updated 22 Jan 2025
Brief summary (registry, in English)
The study aims to explore the effects of Sumatriptan on Levcromakalim-induced migraine in individuals with migraine without aura.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 4 Jan 2022
- Start date
- 15 Mar 2022
- Primary completion date
- 5 Nov 2023
- Lead sponsor
- Danish Headache Center
- Diseases
- Migraine
- NCT number
- NCT05211050
What you commit to
- Study type: Interventional
- Participants enrolled: 24
- From 15 Mar 2022 to the primary completion date, 5 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other illness
- 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.
- 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.
Other
- The participant is at risk of self-harm or harm to others as evidenced by past suicidal behavior.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Danish Headache Centre Coordinator of this site? Confirm its status | Glostrup | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.