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Cholinesterase Inhibitor
Pyridostigmine for Postural Tachycardia Syndrome
Phase 2
Recruiting
Led By Phillip A. Low, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 days
Awards & highlights
Study Summary
This trial will compare the effects of pyridostigmine to placebo in treating postural tachycardia syndrome. The researchers expect that pyridostigmine will improve tachycardia and stabilize blood pressure.
Who is the study for?
This trial is for individuals with Postural Tachycardia Syndrome (POTS), characterized by a rapid increase in heartbeat upon standing. Participants must experience symptoms like weakness, dizziness, blurry vision, nausea, heart palpitations, and concentration issues. Pregnant or breastfeeding women, those with thyroid disorders, significant heart disease or other illnesses affecting the autonomic system are excluded.Check my eligibility
What is being tested?
The study tests pyridostigmine against a placebo over three days to see if it can reduce the fast heartbeat and stabilize blood pressure in POTS patients. The goal is to determine whether pyridostigmine is effective in treating symptoms of POTS compared to an inactive substance.See study design
What are the potential side effects?
While not specified here, common side effects of pyridostigmine may include stomach cramps, diarrhea, increased saliva and urine production, muscle twitching and sweating. Placebo typically has no active ingredients but can cause perceived side effects due to patient expectations.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in orthostatic symptoms using Composite Autonomic Symptom Scale (COMPASS) change
Secondary outcome measures
Heart rate response to head-up tilt
Plasma norepinephrine change
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: pyridostigmineActive Control1 Intervention
Active study drug
Group II: PlaceboPlacebo Group1 Intervention
Control
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,767,090 Total Patients Enrolled
4 Trials studying Postural Orthostatic Tachycardia Syndrome
103 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,340 Previous Clinical Trials
649,314 Total Patients Enrolled
4 Trials studying Postural Orthostatic Tachycardia Syndrome
359 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
National Institutes of Health (NIH)NIH
2,697 Previous Clinical Trials
6,952,764 Total Patients Enrolled
7 Trials studying Postural Orthostatic Tachycardia Syndrome
384 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a condition called postural tachycardia syndrome, which is diagnosed when your heart rate goes up by 30 or more beats per minute within 5 minutes of standing up.You have a thyroid condition that is not under control.You have been diagnosed with postural tachycardia syndrome.Your heart rate increases by 30 or more beats per minute within 5 minutes of standing up.You experience symptoms like feeling weak, dizzy, having blurry vision, feeling sick to your stomach, and having trouble focusing when you stand up.You have a serious illness or organ problems that could affect how your body functions, or you may have trouble following study instructions.You have a serious heart condition related to your arteries.You are taking medications that could affect the results of the autonomic testing.You have not taken pyridostigmine for POTS in the last month.You have been diagnosed with postural tachycardia syndrome, which causes symptoms like feeling dizzy and having trouble concentrating when standing up.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: pyridostigmine
Awards:
This trial has 0 awards, including: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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aggregate count of participants involved in this research?
"Affirmative. Clinicaltrials.gov has evidence of this clinical trial's current recruitment status, which began on October 1st 2006 and was refreshed on March 4th 2022. The study will be enrolling 50 participants from one specific medical centre."
Answered by AI
What are the eligibility requirements to join this research project?
"This scientific investigation is searching for 50 participants with the illness, aged between 15 and 55. If they meet these criteria, they will be eligible to join the trial."
Answered by AI
What medical purposes does pyridostigmine typically serve?
"Pyridostigmine has been seen to ameliorate myasthenia gravis, dyschezia, and orthostatic syncope."
Answered by AI
Might participants older than fifty-five years be qualified to join this research?
"The requirements for enrollment in this trial is that patients must be between the ages of 15 and 55. Separately, there are 388 studies targeting individuals below 18 years old and 1,075 experiments focused on those 65 or older."
Answered by AI
Is enrollment in this scientific experiment still an option for participants?
"This clinical trial, which was initially posted on October 1st 2006 and most recently edited March 4th 2022 is still recruiting participants."
Answered by AI
Have there been other experiments performed with pyridostigmine?
"Currently, 4 clinical trials that focus on pyridostigmine are actively enrolling participants with none of them in Phase 3. Of these locations, there is one based in Nashville, Tennessee and three other study centres scattered across the country."
Answered by AI
Who else is applying?
What site did they apply to?
Mayo Clinic
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2
Why did patients apply to this trial?
I have had POTS symptoms for a few years but recently diagnosed with a Tilt Table test.
PatientReceived 1 prior treatment
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