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Capsaicin, Phenylephrine, Caffeine Combination

The Effect of CPC on Aborting Tilt Induced Syncope in Patients With a History of Vasovagal Syncope or Near Syncope

Phase 2
Waitlist Available
Led By Mohamed H Hamdan, MD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 hours after tilt table testing (up to approximately 8 hours and 35 minutes)
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved

Summary

This trial tests a new under-the-tongue drug called CPC to prevent fainting in people who often experience vasovagal syncope. The drug is given at the first signs of fainting to stop it from happening.

Eligible Conditions
  • Vasovagal Syncope

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 hours after tilt table testing (up to approximately 8 hours and 35 minutes)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 hours after tilt table testing (up to approximately 8 hours and 35 minutes) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants Who Have Hypotensive Syncope or Near Syncope With SBP Less Than or Equal to 70 mmHG During Tilt Test
Time to Syncope or Near-syncope After CPC or Placebo Administration
Secondary study objectives
Fatigue Scores at 1, 4, and 8 Hours Post Tilt Table Testing
Percentage of Patients Who Have Asystolic Pauses > 3 Seconds in the CPC and Placebo Arms

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CPC AdminstrationExperimental Treatment2 Interventions
Single dose of CPC will be given during tilt table test
Group II: Placebo AdminstrationPlacebo Group2 Interventions
Single dose of Placebo will be given during tilt table test
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Caffeine
FDA approved
Tilt Table Test
2021
Completed Phase 2
~150

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,234 Previous Clinical Trials
3,200,148 Total Patients Enrolled
Mohamed H Hamdan, MDPrincipal InvestigatorUniversity of Wisconsin, Madison

Media Library

CPC (Capsaicin, Phenylephrine, Caffeine Combination) Clinical Trial Eligibility Overview. Trial Name: NCT04972123 — Phase 2
Vasovagal Syncope Research Study Groups: CPC Adminstration, Placebo Adminstration
Vasovagal Syncope Clinical Trial 2023: CPC Highlights & Side Effects. Trial Name: NCT04972123 — Phase 2
CPC (Capsaicin, Phenylephrine, Caffeine Combination) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04972123 — Phase 2
~32 spots leftby Dec 2025
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