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

Headache Clinical Trial

— SLIM  

Official title:

Effect of Sumatriptan on Levcromakalim-Induced Symptoms in Individuals With Migraine: A Randomized Double-Blind Two-Way Crossover Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05211050
• Other study ID #: H-21011542
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: January 2022
• Source: Danish Headache Center
• Contact: Messoud Ashina, Prof.
• Phone: +45 38 63 33 85
• Email: messoud.ashina[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Opening of adenosine triphosphate-sensitive potassium (KATP) channels using Levcromakalim cause 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

2. Age =18 years upon entry into screening.

3. 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 Criteria:

1. 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.

2. 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.

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

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

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 past suicidal behavior.

7. 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.

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

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

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

11. 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.

Related Conditions & MeSH terms

• Headache
• Migraine Disorders
• Migraine without Aura

Intervention

Drug:
• Levcromakalim
20 min infusion of 1 mg Levcromakalim followed by either sumatriptan or placebo.
• Sumatriptan
10 min infusion of 4 mg sumatriptan.
• Saline
10 min infusion of isotonic saline (placebo).

Locations

Country	Name	City	State
Denmark	Danish Headache Centre	Glostrup	Zealand

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of facial flushing	Incidence of facial skin flushing assessed by the investigator as a binary outcome.	Assessed from baseline to 2 hours after infusion of levcromakalim.
Other	Facial blood flow assessed using Laser Doppler Flowmetry	Facial blood flow is measured as a continuous outcome using Laser Doppler Flowmetry (LDI, Moor Instruments, Devon, United Kingdom).	Assessed from baseline to 2 hours after infusion of levcromakalim.
Other	Facial temperature assessed using FLIR infrared thermal camera	Facial temperature is measured as a continuous outcome using FLIR infrared thermal camera (FLIR A655sc, Flir Systems, Sweden)	Assessed from baseline to 2 hours after infusion of levcromakalim.
Primary	Incidence of migraine attacks	A migraine attack is defined as an attack fulfilling either (i) or (ii): (i) Headache fulfilling criteria C and D for migraine without aura according to the International Classification of Headache Disorders 3rd edition: C. Headache has at least two of the following characteristics: unilateral location; pulsating quality; moderate or severe pain intensity (moderate to severe pain intensity is considered =4 on the numerical rating scale); aggravation by cough (in-hospital phase) or causing avoidance of routine physical activity (out-hospital phase); D. During headache at least one of the following: nausea and/or vomiting; photophobia and phonophobia; (ii) Headache described as mimicking the patient's usual migraine attack and treated with acute migraine medication (rescue medication).	Assessed from baseline to 12 hours after infusion of levcromakalim.
Secondary	Incidence of headache	Incidence of headache is defined as headache intensity =1 as measured by a numerical rating scale (NRS) from 0 to 10. It is a verbally declared scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.	Assessed from baseline to 12 hours after infusion of levcromakalim.
Secondary	Intensity of headache	Headache intensity scores are measured by a numerical rating scale (NRS). It is a verbally declared scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.	Assessed from baseline to 12 hours after infusion of levcromakalim.
Secondary	Diameter of superficial temporal artery (STA) assessed using high frequency ultrasound	Diameter (mm) of superficial temporal artery (STA) is measured as a continuous outcome using high frequency ultrasound (Dermascan C, Cortex Technology, Denmark).	Assessed from baseline to 2 hours after infusion of levcromakalim.
Secondary	Incidence of adverse events	Participants are instructed to inform the investigators in the case of adverse events.	Assessed from baseline to 12 hours after infusion of levcromakalim.