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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 up to 5 years
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.
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.
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 ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: pyridostigmineActive Control1 Intervention
Active study drug
Group II: PlaceboPlacebo Group1 Intervention
Control
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,360 Previous Clinical Trials
3,065,891 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
1,384 Previous Clinical Trials
652,638 Total Patients Enrolled
4 Trials studying Postural Orthostatic Tachycardia Syndrome
359 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
National Institutes of Health (NIH)NIH
2,840 Previous Clinical Trials
8,172,068 Total Patients Enrolled
7 Trials studying Postural Orthostatic Tachycardia Syndrome
544 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Phillip A. Low, M.D.Principal InvestigatorMayo Clinic
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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.