Syncope, VasovagalPhase 2NCT04972123
The Effect of CPC on Aborting Tilt Induced Syncope in Patients With a History of Vasovagal Syncope or Near Syncope
A Phase 2 study testing CPC - Capsaicin, Phenylephrine, Caffeine and Tilt Table Test in people with Syncope, Vasovagal, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Syncope is defined as transient loss of consciousness associated with inability to maintain postural tone with rapid and spontaneous recovery. The purpose of this study is to assess the effects of sublingual administration of a new medication called CPC on tilt-induced syncope in patients with a history of vasovagal… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Syncope, Vasovagal
- What is being tested?
- CPC - Capsaicin, Phenylephrine, Caffeine and Tilt Table Test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2021to 31 Aug 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Established diagnosis of typical vasovagal syncope or near syncope
- Age 18-50 years
Who cannot join
- Systolic BP >130 mmHg
- History of hypertension or cardiac arrhythmias
- History of cardiovascular disease or cerebral ischemic events
- Allergic reaction to any of the drug components
- Contraindication to tilt testing
- Any physical or psychological symptom, based on the clinical judgment of the investigators that would make a participant unsuitable for the study
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- Any use of a medication(s) based on the clinical judgment of the investigators that would make a participant unsuitable for the study (e.g. fludrocortisone, theophylline, prazosin, doxazosin, terazosin, MAO-inhibitors, pseudoephedrine, decongestant and PDE5 inhibitors).
- Unwilling to discontinue Midodrine or beta-blocker therapy 48 hours before tilt table testing.
- Women who are pregnant (confirmed with pregnancy test on day of study) or lactating.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin- Madsion
Madison, Wisconsin, 53792
About this study
Official title: The Effect of Capsaicin-Phenylephrine-Caffeine Formulation on Aborting Tilt Induced Syncope in Patients With a History of Vasovagal Syncope or Near Syncope
Syncope is defined as transient loss of consciousness associated with inability to maintain postural tone with rapid and spontaneous recovery. The purpose of this study is to assess the effects of sublingual administration of a new medication called CPC on tilt-induced syncope in patients with a history of vasovagal syncope (VVS) or near syncope. 140 participants will be randomized at the University of Wisconsin - Madison. Each participant will be in the study for 1 day.
Read the detailed description
Vasovagal syncope (VVS) is the most common type of syncope. The mechanism is reflex-mediated triggered by various afferent input to the brain. The event is usually preceded by diaphoresis, warmth, nausea, and pallor, and is followed by fatigue. While several drugs are indicated in the treatment of VVS, to our knowledge, there is no current treatment of an impending syncopal attack. In the present study, the investigators hypothesized that a single administration of sublingual CPC preparation during the prodromal phase would abort tilt-induced syncope or near syncope with SBP less than or equal to 70 mmHg in patients with a history of VVS. Patients with an established diagnosis of typical VVS or near syncope will be randomized to receive CPC or placebo in 1:1 ratio. Drug or placebo will be administered at the onset of prodromes during tilt table testing. In addition to the primary endpoint (syncope or near syncope with SBP less than or equal to 70 mmHg), the investigators will be assessing the effects of the drug on time to event, incidence of asystole (> 3 sec), and fatigue after syncope.
- Conditions
- Syncope, Vasovagal
- Being tested
- CPC - Capsaicin, Phenylephrine, Caffeine, Tilt Table Test, Placebo
- Keywords
- Neurocardiogenic Syncope, Reflex Syncope, Fainting Spells
- Medical subject headings
- Syncope, Vasovagal, Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPC - Capsaicin, Phenylephrine, CaffeineDrug
CPC is a combination of Capsaicin, Phenylephrine and Caffeine
Tilt Table TestDiagnostic test
Participant will undergo tilt tablet testing using the Italian protocol (see reference section). The Italian protocol includes 20 minutes of passive tilt at 70 degrees (Passive Phase) followed by nitroglycerin (NTG) administration and tilt testing for another 15 minutes (NTG Phase).
PlaceboDrug
Placebo for CPC
| Study group | Role | What they receive |
|---|---|---|
| CPC Adminstration | Experimental | Single dose of CPC will be given during tilt table test Receives: Drug: CPC - Capsaicin, Phenylephrine, Caffeine; Diagnostic Test: Tilt Table Test |
| Placebo Adminstration | Placebo comparator | Single dose of Placebo will be given during tilt table test Receives: Diagnostic Test: Tilt Table Test; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Have Hypotensive Syncope or Near Syncope With SBP Less Than or Equal to 70 mmHG During Tilt Test
Hypotensive syncope is defined as transient loss of consciousness associated with SBP less than or equal to 90 mmHg. Near syncope is defined as sensation of "near fainting" while still being responsive to verbal commands. Near syncope will be used as a primary endpoint only when it is associated with a SBP less than or equal to 70 mmHg.
Measured: During tilt table testing (up to approximately 35 minutes)
Time to Syncope or Near-syncope After CPC or Placebo Administration
Time in seconds from CPC or Placebo administration to syncope or near syncope in patients who had an event
Measured: During tilt table testing (up to approximately 35 minutes)
Secondary outcomes (2)
Percentage of Patients Who Have Asystolic Pauses > 3 Seconds in the CPC and Placebo Arms
Percentage of Participants with an event who had asystolic pauses > 3 seconds during syncope or near syncope
Measured: During tilt table testing (up to approximately 35 minutes)
Fatigue Scores at 1, 4, and 8 Hours Post Tilt Table Testing
Fatigue Scores at 1, 4 and 8 hours post tilt table testing in participants who had an event. Using standard continuous fatigue scale of 1 to 5, with 1 = no fatigue and 5 = max fatigue.
Measured: Up to 8 hours after tilt table testing (up to approximately 8 hours and 35 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start20 Jul 2021
- Primary completion25 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Syncope, VasovagalStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed H Hamdan, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972123
- Sponsor's protocol ID
- 2021-0081
- Other IDs
- Protocol Version 4/12/2022, A534225, SMPH/MEDICINE/CARDIOLOGY
- Status last verified
- Jun 2024
- First submitted
- 12 Jul 2021
- Last updated
- 17 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bartoletti A, Alboni P, Ammirati F, Brignole M, Del Rosso A, Foglia Manzillo G, Menozzi C, Raviele A, Sutton R. 'The Italian Protocol': a simplified head-up tilt testing potentiated with oral nitroglycerin to assess patients with unexplained syncope. Europace. 2000 Oct;2(4):339-42. doi: 10.1053/eupc.2000.0125.
PubMed 11194602
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Capsaicin-Phenylephrine-Caffeine Formulation on Aborting Tilt Induced Syncope in Patients With a History of Vasovagal Syncope or Near Syncope
- ClinicalTrials.gov ID
- NCT04972123
- Acronym / sponsor ID
- 2021-0081
- Conditions
- Syncope, Vasovagal
- Keywords
- Neurocardiogenic Syncope, Reflex Syncope, Fainting Spells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 25 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 22 Jul 2021 (actual)
- Results
- Posted 24 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Syncope is defined as transient loss of consciousness associated with inability to maintain postural tone with rapid and spontaneous recovery. The purpose of this study is to assess the effects of sublingual administration of a new medication called CPC on tilt-induced syncope in patients with a history of vasovagal syncope (VVS) or near syncope. 140 participants will be randomized at the University of Wisconsin - Madison. Each participant will be in the study for 1 day.
Detailed description
Vasovagal syncope (VVS) is the most common type of syncope. The mechanism is reflex-mediated triggered by various afferent input to the brain. The event is usually preceded by diaphoresis, warmth, nausea, and pallor, and is followed by fatigue. While several drugs are indicated in the treatment of VVS, to our knowledge, there is no current treatment of an impending syncopal attack. In the present study, the investigators hypothesized that a single administration of sublingual CPC preparation during the prodromal phase would abort tilt-induced syncope or near syncope with SBP less than or equal to 70 mmHg in patients with a history of VVS. Patients with an established diagnosis of typical VVS or near syncope will be randomized to receive CPC or placebo in 1:1 ratio. Drug or placebo will be administered at the onset of prodromes during tilt table testing. In addition to the primary endpoint (syncope or near syncope with SBP less than or equal to 70 mmHg), the investigators will be assessing the effects of the drug on time to event, incidence of asystole (> 3 sec), and fatigue after syncope.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPC Adminstration | Experimental | Drug: CPC - Capsaicin, Phenylephrine, Caffeine, Diagnostic Test: Tilt Table TestSingle dose of CPC will be given during tilt table test |
| Placebo Adminstration | Placebo comparator | Diagnostic Test: Tilt Table Test, Drug: PlaceboSingle dose of Placebo will be given during tilt table test |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Established diagnosis of typical vasovagal syncope or near syncope
- Age 18-50 years
Key exclusion criteria (9 listed)
- Systolic BP >130 mmHg
- History of hypertension or cardiac arrhythmias
- History of cardiovascular disease or cerebral ischemic events
- Allergic reaction to any of the drug components
- Contraindication to tilt testing
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 |
|---|---|---|
| CPC - Capsaicin, Phenylephrine, CaffeineCPC is a combination of Capsaicin, Phenylephrine and Caffeine | Drug | CPC Adminstration |
| Tilt Table TestParticipant will undergo tilt tablet testing using the Italian protocol (see reference section). The Italian protocol includes 20 minutes of passive tilt at 70 degrees (Passive Phase) followed by nitroglycerin (NTG) administration and tilt testing for another 15 minutes (NTG Phase). | Diagnostic test | CPC Adminstration, Placebo Adminstration |
| PlaceboPlacebo for CPC | Drug | Placebo Adminstration |
Primary outcome
Percentage of Participants Who Have Hypotensive Syncope or Near Syncope With SBP Less Than or Equal to 70 mmHG During Tilt Test
Time frame: During tilt table testing (up to approximately 35 minutes)
Hypotensive syncope is defined as transient loss of consciousness associated with SBP less than or equal to 90 mmHg. Near syncope is defined as sensation of "near fainting" while still being responsive to verbal commands. Near syncope will be used as a primary endpoint only when it is associated with a SBP less than or equal to 70 mmHg.
Time to Syncope or Near-syncope After CPC or Placebo Administration
Time frame: During tilt table testing (up to approximately 35 minutes)
Time in seconds from CPC or Placebo administration to syncope or near syncope in patients who had an event
2 secondary outcomes
Percentage of Patients Who Have Asystolic Pauses > 3 Seconds in the CPC and Placebo Arms
Time frame: During tilt table testing (up to approximately 35 minutes)
Fatigue Scores at 1, 4, and 8 Hours Post Tilt Table Testing
Time frame: Up to 8 hours after tilt table testing (up to approximately 8 hours and 35 minutes)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11194602Bartoletti A, Alboni P, Ammirati F, Brignole M, Del Rosso A, Foglia Manzillo G, Menozzi C, Raviele A, Sutton R. 'The Italian Protocol': a simplified head-up tilt testing potentiated with oral nitroglycerin to assess patients with unexplained syncope. Europace. 2000 Oct;2(4):339-42. doi: 10.1053/eupc.2000.0125.
- Individual participant dataSharing planned: No
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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.
Mohamed H Hamdan, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CPC - Capsaicin, Phenylephrine, Caffeine and Tilt Table Test in people with Syncope, Vasovagal, run by University of Wisconsin, Madison at 1 site in United States.
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 2 inclusion and 9 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 17 Jul 2024. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Who Have Hypotensive Syncope or Near Syncope With SBP Less Than or Equal to 70 mmHG During Tilt Test (time frame: During tilt table testing (up to approximately 35 minutes)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04972123, which also lists 1 linked publication.
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 17 Jul 2024.