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

NCT05211050 | Completed

• 1 other identifier: H-21011542
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Migraine Without Aura; Headache

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Incidence of headache

  Assessed from baseline to 12 hours after infusion of levcromakalim.

• Intensity of headache

  Assessed from baseline to 12 hours after infusion of levcromakalim.

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

  Assessed from baseline to 2 hours after infusion of levcromakalim.

• Incidence of adverse events

  Assessed from baseline to 12 hours after infusion of levcromakalim.

Other Outcomes (2)

• Incidence of facial flushing

  Assessed from baseline to 2 hours after infusion of levcromakalim.

• Facial blood flow assessed using Laser Doppler Flowmetry

  Assessed from baseline to 2 hours after infusion of levcromakalim.

Study Arms (2)

Levcromakalim-Sumatriptan

ACTIVE COMPARATOR

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

Drug: Levcromakalim; Drug: Sumatriptan

Levcromakalim-Placebo

PLACEBO COMPARATOR

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

Drug: Levcromakalim; Drug: Saline

Interventions

Levcromakalim DRUG

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

Levcromakalim-Placebo; Levcromakalim-Sumatriptan

Sumatriptan DRUG

10 min infusion of 4 mg sumatriptan.

Levcromakalim-Sumatriptan

Saline DRUG

10 min infusion of isotonic saline (placebo).

Levcromakalim-Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Danish Headache Centre

Glostrup, Region Sjælland, 2600, Denmark

Location

MeSH Terms

Conditions

Migraine without Aura; Headache

Interventions

Cromakalim; Sumatriptan; Sodium Chloride

Condition Hierarchy (Ancestors)

Migraine Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Messoud Ashina, Prof.

  Danish Headache Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 27, 2022
• Study Start: March 15, 2022
• Primary Completion: November 5, 2023
• Study Completion: November 5, 2023
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

DK (1)