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

NCT ID: NCT05211050

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-15
• Study Completion Date: 2023-11-05

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 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.

Conditions

Migraine Without Aura; Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Levcromakalim-Sumatriptan

20 participants with migraine without aura will receive a 20 min infusion of levcromakalim followed by a 10 min infusion of sumatriptan.

Group Type: ACTIVE_COMPARATOR

Levcromakalim

Intervention Type: DRUG

20 min infusion of 1 mg Levcromakalim followed by either sumatriptan or placebo.

Sumatriptan

Intervention Type: DRUG

10 min infusion of 4 mg sumatriptan.

Levcromakalim-Placebo

20 participants with migraine without aura will receive a 20 min infusion of levcromakalim followed by a 10 min infusion of saline.

Group Type: PLACEBO_COMPARATOR

Levcromakalim

Intervention Type: DRUG

20 min infusion of 1 mg Levcromakalim followed by either sumatriptan or placebo.

Saline

Intervention Type: DRUG

10 min infusion of isotonic saline (placebo).

Interventions

Levcromakalim

20 min infusion of 1 mg Levcromakalim followed by either sumatriptan or placebo.

Intervention Type: DRUG

Sumatriptan

10 min infusion of 4 mg sumatriptan.

Intervention Type: DRUG

Saline

10 min infusion of isotonic saline (placebo).

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Danish Headache Center

OTHER

Sponsor Role: lead

Responsible Party

Messoud Ashina, MD

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Messoud Ashina, Prof.

Role: PRINCIPAL_INVESTIGATOR

Danish Headache Center

Locations

Danish Headache Centre

Glostrup, Region Sjælland, Denmark

Countries

Denmark

Other Identifiers

H-21011542

Identifier Type: -

Identifier Source: org_study_id