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

Primary Purpose

Migraine Without Aura, Headache

Status

Recruiting

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Levcromakalim

Sumatriptan

Saline

About this trial

This is an interventional other trial for Migraine Without Aura

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

Danish Headache CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Levcromakalim-Sumatriptan

Levcromakalim-Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

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.

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).

Incidence of adverse events

Participants are instructed to inform the investigators in the case of adverse events.

Full Information

NCT ID

NCT05211050

First Posted

January 4, 2022

Last Updated

January 26, 2022

Sponsor

Danish Headache Center

1. Study Identification

Unique Protocol Identification Number

NCT05211050

Brief Title

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

Acronym

SLIM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 15, 2022 (Anticipated)

Primary Completion Date

January 1, 2025 (Anticipated)

Study Completion Date

January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Danish Headache Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Migraine Without Aura, Headache

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Levcromakalim-Sumatriptan

Arm Type

Active Comparator

Arm Description

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

Arm Title

Levcromakalim-Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Levcromakalim

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Sumatriptan

Intervention Description

10 min infusion of 4 mg sumatriptan.

Intervention Type

Drug

Intervention Name(s)

Saline

Intervention Description

10 min infusion of isotonic saline (placebo).

Primary Outcome Measure Information:

Title

Incidence of migraine attacks

Description

Time Frame

Assessed from baseline to 12 hours after infusion of levcromakalim.

Secondary Outcome Measure Information:

Title

Incidence of headache

Description

Time Frame

Assessed from baseline to 12 hours after infusion of levcromakalim.

Title

Intensity of headache

Description

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.

Time Frame

Assessed from baseline to 12 hours after infusion of levcromakalim.

Title

Diameter of superficial temporal artery (STA) assessed using high frequency ultrasound

Description

Diameter (mm) of superficial temporal artery (STA) is measured as a continuous outcome using high frequency ultrasound (Dermascan C, Cortex Technology, Denmark).

Time Frame

Assessed from baseline to 2 hours after infusion of levcromakalim.

Title

Incidence of adverse events

Description

Participants are instructed to inform the investigators in the case of adverse events.

Time Frame

Assessed from baseline to 12 hours after infusion of levcromakalim.

Other Pre-specified Outcome Measures:

Title

Incidence of facial flushing

Description

Incidence of facial skin flushing assessed by the investigator as a binary outcome.

Time Frame

Assessed from baseline to 2 hours after infusion of levcromakalim.

Title

Facial blood flow assessed using Laser Doppler Flowmetry

Description

Facial blood flow is measured as a continuous outcome using Laser Doppler Flowmetry (LDI, Moor Instruments, Devon, United Kingdom).

Time Frame

Assessed from baseline to 2 hours after infusion of levcromakalim.

Title

Facial temperature assessed using FLIR infrared thermal camera

Description

Facial temperature is measured as a continuous outcome using FLIR infrared thermal camera (FLIR A655sc, Flir Systems, Sweden)

Time Frame

Assessed from baseline to 2 hours after infusion of levcromakalim.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Messoud Ashina, Prof.

Phone

+45 38 63 33 85

messoud.ashina@regionh.dk

First Name & Middle Initial & Last Name or Official Title & Degree

Mohammad Al-Mahdi Al-Karagholi, MD, PhD

Phone

+45 31 19 16 47

mahdi.alkaragholi@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Messoud Ashina, Prof.

Organizational Affiliation

Danish Headache Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Danish Headache Centre

City

Glostrup

State/Province

Zealand

ZIP/Postal Code

2600

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Messoud Ashina, Prof.

Phone

+45 38 63 33 85

ashina@dadlnet.dk

12. IPD Sharing Statement

Learn more about this trial

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

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