MigraineNCT05654298
Influence of Ubrogepant and Sumatriptan on the Dermal Blood Flow Response to Histamine, Cinnamaldehyde and Capsaicin
A study testing Sumatriptan and Ubrogepant in people with Migraine, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- Sumatriptan and Ubrogepant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Mar 2022to 15 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is a white male ≥ 18 and ≤ 45 years of age at the time of screening.
- Subject is a nonsmoker for at least 6 months prior to the study start.
- Subject has a body mass index ≥ 18 and ≤ 30 kg/m2.
- Subject has a clear increase in histamine-induced dermal blood flow.
- Subject has an increase in capsaicin- and cinnamaldehyde-induced dermal blood flow of at least 100% as determined during the screening visit.
- Subject is judged to be in good health on the basis of medical history, physical examination and vital signs.
- Subject understands the procedures and agrees to comply with them for the entire length of the study by giving written informed consent.
Who cannot join
- Subject has excessive hair growth on the volar surface of the forearm.
- Subject has a past or present history of diffuse dermatological conditions including eczema, scleroderma, psoriasis, urticaria, dermatographism and dermatitis.
- 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.
- 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.
- 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.
- Subject has a past or present history of (symptomatic) asthma.
Show all 17Show fewer
- 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.
- 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.
- 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.
- 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.
- Subject cannot refrain from being around secondhand smoke 24 hours prior to histamine application or uses nicotine-containing products. Ex-smokers should have ceased smoking at least 6 months prior to screening.
- Subject has any of the following vital sign measurements at screening: heart rate ≤ 40 or ≥ 100 beats/min, diastolic blood pressure ≤ 50 or ≥ 89 mmHg and/or systolic Blood Pressure ≤ 90 or ≥ 139 mmHg.
- Subject has been involved in testing an investigational drug in another clinical study within the last 4 weeks or 5 half-lives.
- Subject has evidence of a clinically significant active infection, fever of 38°C or above at the time of the study visits.
- Subject has a history or current cardiovascular (e.g. myocardial infarction, ischemic heart disease, coronary vasospasm, peripheral vascular disease, mild or severe hypertension or mild uncontrolled hypertension and patients who show symptoms of ischemic heart disease,), respiratory, hepatic (e.g. severe liver insufficiency), renal (e.g. severe renal impairment), gastrointestinal or neurological (e.g. cerebrovascular accident or transient ischemic attacks) disorders capable of significantly altering the absorption, metabolism or elimination of drugs.
- Subject is in a situation or has a condition, which, in the opinion of the investigator, may interfere with safe and optimal participation in the study.
- Subject has a history of any illness or disorder, which, in the opinion of the investigator, might confound the results of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Migraine
- Being tested
- Sumatriptan, Ubrogepant
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SumatriptanDrug
Sumatriptan 100 mg
UbrogepantDrug
Ubrogepant 100 mg
| Study group | Role | What they receive |
|---|---|---|
| Ubrogepant | Experimental | Not described Receives: Drug: Ubrogepant |
| Sumatriptan | Experimental | Not described Receives: Drug: Sumatriptan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dermal Blood Flow induced by topical application of cinnamaldehyde
Measured: AUC(0-60minutes)
Change in Dermal Blood Flow induced by topical application of capsaicin
Measured: AUC(0-60minutes)
Change in Dermal Blood Flow induced by histamine Skin Prick Test
Measured: AUC(0-60minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start15 Mar 2022
- Primary completion15 Mar 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654298
- Sponsor's protocol ID
- CCP18-3305-HIS Part IV
- Status last verified
- Mar 2022
- First submitted
- 8 Dec 2022
- Last updated
- 28 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05654298
- Acronym / sponsor ID
- CCP18-3305-HIS Part IV
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ubrogepant | Experimental | Drug: Ubrogepant |
| Sumatriptan | Experimental | Drug: Sumatriptan |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject is a white male ≥ 18 and ≤ 45 years of age at the time of screening.
- Subject is a nonsmoker for at least 6 months prior to the study start.
- Subject has a body mass index ≥ 18 and ≤ 30 kg/m2.
- Subject has a clear increase in histamine-induced dermal blood flow.
- Subject has an increase in capsaicin- and cinnamaldehyde-induced dermal blood flow of at least 100% as determined during the screening visit.
Key exclusion criteria (17 listed)
- Subject has excessive hair growth on the volar surface of the forearm.
- Subject has a past or present history of diffuse dermatological conditions including eczema, scleroderma, psoriasis, urticaria, dermatographism and dermatitis.
- 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.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SumatriptanSumatriptan 100 mg | Drug | Sumatriptan |
| UbrogepantUbrogepant 100 mg | Drug | Ubrogepant |
Primary outcome
Change in Dermal Blood Flow induced by topical application of cinnamaldehyde
Time frame: AUC(0-60minutes)
Change in Dermal Blood Flow induced by topical application of capsaicin
Time frame: AUC(0-60minutes)
Change in Dermal Blood Flow induced by histamine Skin Prick Test
Time frame: AUC(0-60minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
Related trials for Migraine
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Enrolling by invitation
App-based Breathing Program for Migraine Relief
Migraine, Heart Rate Variability (HRV)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sumatriptan and Ubrogepant in people with Migraine, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dermal Blood Flow induced by topical application of cinnamaldehyde (time frame: AUC(0-60minutes)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.