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Capsaicin, Phenylephrine, Caffeine Combination
CPC - Capsaicin, Phenylephrine, Caffeine for Vasovagal 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 during tilt table testing (up 35 minutes)
Awards & highlights
Study Summary
This trial will test the effects of a new medication, CPC, on people with a history of fainting spells brought on by sudden changes in position.
Eligible Conditions
- Vasovagal Syncope
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during tilt table testing (up 35 minutes)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during tilt table testing (up 35 minutes)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of participants who have hypotensive syncope or near syncope with SBP less than or equal to 70 mmHG during tilt test
Secondary outcome measures
Fatigue Score at 1, 4, and 8 hours post tilt table testing
Percentage of patients who have asystolic pauses > 3 sec in the CPC and placebo arms
Time to syncope or near-syncope after CPC or placebo administration
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
~140
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Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,193 Previous Clinical Trials
3,161,699 Total Patients Enrolled
Mohamed H Hamdan, MDPrincipal InvestigatorUniversity of Wisconsin, Madison
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot undergo tilt testing due to a medical condition.You cannot take your Midodrine or beta-blocker medication 48 hours before the tilt table test.You have a confirmed diagnosis of vasovagal syncope or near syncope.If the study investigators feel that any physical or psychological symptom would make you unsuitable for the study.You are taking medication(s) that the study team thinks would make you ineligible for the study. Examples include fludrocortisone, theophylline, prazosin, doxazosin, terazosin, MAO-inhibitors, pseudoephedrine, decongestant, and PDE5 inhibitors.You have a history of heart or brain problems.
Research Study Groups:
This trial has the following groups:- Group 1: CPC Adminstration
- Group 2: Placebo Adminstration
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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