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Influence of Ubrogepant and Sumatriptan on the Dermal Blood Flow Response to Histamine, Cinnamaldehyde and Capsaicin | Clinical Trials | Clareo Health

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Influence of Ubrogepant and Sumatriptan on the Dermal Blood Flow Response to Histamine, Cinnamaldehyde and Capsaicin

Influence of Ubrogepant and Sumatriptan on the Dermal Blood Flow Response After a Histamine Skin Prick as Well as After the Topical Application of Cinnamaldehyde and Capsaicin

NCT05654298•Universitaire Ziekenhuizen KU Leuven

View on ClinicalTrials.gov

Summary

The involvement of calcitonin gene-related peptide (CGRP) in the cinnamaldehyde-induced dermal blood flow increase and in the mechanism of action of triptans will be investigated. The capsaicin-induced dermal blood flow will be incorporated as a positive control; histamine skin pricks as a negative control. Changes in dermal blood flow will be measured with laser speckle contrast imaging.

Eligibility

Age

18 - 45 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. Subject is a white male ≥ 18 and ≤ 45 years of age at the time of screening.
•2. Subject is a nonsmoker for at least 6 months prior to the study start.
•3. Subject has a body mass index ≥ 18 and ≤ 30 kg/m2.
•4. Subject has a clear increase in histamine-induced dermal blood flow.
•5. Subject has an increase in capsaicin- and cinnamaldehyde-induced dermal blood flow of at least 100% as determined during the screening visit.
•6. Subject is judged to be in good health on the basis of medical history, physical examination and vital signs.
•7. Subject understands the procedures and agrees to comply with them for the entire length of the study by giving written informed consent.

Exclusion Criteria

•1. Subject has excessive hair growth on the volar surface of the forearm.
•2. Subject has a past or present history of diffuse dermatological conditions including eczema, scleroderma, psoriasis, urticaria, dermatographism and dermatitis.
•3. Subject has any abnormality on the skin of the forearm, possibly interfering with the study assessments including tattoos, keloids, tumors, ulcers, burns, flaps and grafts.
•4. Subject cannot avoid excessive tanning (any exposure to sunlight or a tanning bed which would cause a sunburn reaction) throughout the study and cannot cover the forearms 24 hours before and after each study visit.
•5. Subject currently uses lotions, oils, depilatory preparations, makeup or other topical treatments on the arms and on a regular basis which cannot be discontinued for the duration of the study; subject has used any topical treatments within 7 days of the start of the study.
•6. Subject has a past or present history of (symptomatic) asthma.
•7. Subject has a history of severe allergic reactions to food or drugs or adverse experiences of a serious nature related to the administration of either a marketed or investigational drug, including histamine, cinnamaldehyde, capsaicin, ubrogepant or sumatriptan.
•8. Subject currently uses any prescription or nonprescription drugs on a regular basis which cannot be discontinued for the duration of the study; subject has used any prescription or nonprescription medication within 14 days or 5 half-lives of the start of the study.
•9. Subject is a habitual and heavy consumer of coffee or caffeinated beverages (more than approximately 4 cups of tea, coffee or cola per day) at the time of the study. Subjects who have reduced their consumption to ≤ 4 cups per day at least 1 week prior to enrollment may participate. Subjects who cannot refrain from caffeinated beverages 24 hours before the study visit.
•10. Subject is unable to refrain from drinking alcohol 24 hours prior to histamine application, is currently a regular user (including "recreational use") of any illicit drugs, or has a history of drug (including alcohol) abuse. A drug screen will include amphetamines/ methamphetamines, methylenedioxymethamphetamine, benzodiazepines, barbiturates, cocaine, cannabis, tricyclic antidepressants, methadone and opiates.
+7 more criteria

Locations (1)

Center for Clinical Pharmacology

Leuven, Belgium

Key Dates

Start Date

March 15, 2022

Primary Completion Date

March 15, 2023

Completion Date

March 15, 2023

Last Updated

March 28, 2023

Enrollment

ACTUAL participants

Conditions

Migraine

Interventions

Sumatriptan

DRUG

Ubrogepant

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 28, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Influence of Ubrogepant and Sumatriptan on the Dermal Blood Flow Response to Histamine, Cinnamaldehyde and Capsaicin

Inclusion Criteria

Exclusion Criteria

A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

Mind Body Balance for Pediatric Migraine

Light Exposure, Migraine Outcomes, and Sleep Quality

A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine

Prophylactic Treatment With Atorvastatin for Episodic Migraine.