A Phase 2 interventional study of CPC - Capsaicin, Phenylephrine, Caffeine and Tilt Table Test in Syncope, Vasovagal, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-07-17.
Sponsored by University of Wisconsin, Madison · Phase 2, Interventional, and Treatment
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.
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.
226 studies on the registry are indexed under Syncope; 45 are open to participants now.
This study's enrollment of 143 is above the median of 79 across 126 interventional studies indexed under Syncope.
Browse Syncope studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single dose of CPC will be given during tilt table test
Drug: CPC - Capsaicin, Phenylephrine, Caffeine · Diagnostic Test: Tilt Table Test
Single dose of Placebo will be given during tilt table test
Diagnostic Test: Tilt Table Test · Drug: Placebo
CPC is a combination of Capsaicin, Phenylephrine and Caffeine
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).
Placebo for CPC
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.
Time frame: 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
Time frame: During tilt table testing (up to approximately 35 minutes)
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
Time frame: 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.
Time frame: Up to 8 hours after tilt table testing (up to approximately 8 hours and 35 minutes)
Participants were recruited at the University of Wisconsin- Madison using general recruitment emails addressed to students, faculty and staff and UW Heath Faint and Fall Clinic patients. All participants signed electronic consents in advance of study visit. The first participant completed the study in July 2021, and the last participant completed the study in August 2023.
| Milestone | CPC Adminstration | Placebo Adminstration |
|---|---|---|
| Started | 66 | 63 |
| Primary analysis population | 65 | 62 |
| Secondary analysis population | 32 | 27 |
| Completed | 66 | 63 |
| Not completed | 0 | 0 |
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.
| Participants | CPC Adminstration | Placebo Administration |
|---|---|---|
| Number of participants with syncope or near syncope event | 32 | 27 |
| Number of participants without syncope or near syncope event | 33 | 35 |
Time in seconds from CPC or Placebo administration to syncope or near syncope in patients who had an event
| seconds | CPC Administration | Placebo Administration |
|---|---|---|
| Time to Syncope or Near-syncope After CPC or Placebo Administration | 90.1 ± 95.0 | 76.9 ± 95.0 |
Percentage of Participants with an event who had asystolic pauses \> 3 seconds during syncope or near syncope
| Participants | CPC Administration | Placebo Administration |
|---|---|---|
| Percentage of Patients Who Have Asystolic Pauses > 3 Seconds in the CPC and Placebo Arms | 2 | 1 |
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.
| Score on a scale | CPC Adminstration | Placebo Administration |
|---|---|---|
| Fatigue rated at 1 hour post tilt test | 2.2 ± 1.05 | 2.0 ± 0.85 |
| Fatigue rated at 4 hour post tilt test | 2.2 ± 1.09 | 2.3 ± 1.07 |
| Fatigue rated at 8 hour post tilt test | 1.9 ± 0.91 | 2.6 ± 1.39 |
Collected over Start of study visit to 8 hours post CPC or Placebo administration. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CPC Adminstration | 0/66 (0%) | 0/66 (0%) | 3/66 (4.5%) |
| Placebo Administration | 0/63 (0%) | 0/63 (0%) | 4/63 (6.3%) |
| Event | CPC Adminstration | Placebo Administration |
|---|---|---|
| HeadacheNervous system disorders | 1/66 | 3/63 |
| Abdominal pain upperGastrointestinal disorders | 2/66 | 0/63 |
| Migraine HeadacheNervous system disorders | 0/66 | 1/63 |
| NauseaGastrointestinal disorders | 1/66 | 0/63 |
Evaluable participants for intention to treat primary endpoint By protocol entry criteria the age range was 18 to 50 Years.
| Age, Continuous(Years) | CPC Adminstration | Placebo Administration | Total |
|---|---|---|---|
| Median | 26.2 ± 7.1 | 26.2 ± 7.5 | 26.2 ± 7.3 |
| Sex: Female, Male(Participants) | CPC Adminstration | Placebo Administration | Total |
|---|---|---|---|
| Female | 55 | 55 | 110 |
| Male | 10 | 7 | 17 |
| Ethnicity (NIH/OMB)(Participants) | CPC Adminstration | Placebo Administration | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 2 | 6 |
| Not Hispanic or Latino | 54 | 55 | 109 |
| Unknown or Not Reported | 7 | 5 | 12 |
| Race (NIH/OMB)(Participants) | CPC Adminstration | Placebo Administration | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 5 | 6 | 11 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 0 | 3 |
| White | 48 | 47 | 95 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 8 | 9 | 17 |
| Region of Enrollment(participants) | CPC Adminstration | Placebo Administration | Total |
|---|---|---|---|
| United States | 65 | 62 | 127 |
| Syncope History(Participants) | CPC Adminstration | Placebo Administration | Total |
|---|---|---|---|
| Participants with a history of syncope | 60 | 58 | 118 |
| Participant with a history of near syncope | 5 | 4 | 9 |
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University of Wisconsin, Madison