Recruiting
Phase 2

Pyridostigmine

Sponsor:

Mayo Clinic

Code:

NCT00409435

Conditions

Postural Tachycardia Syndrome

Eligibility Criteria

Sex: All

Age: 15 - 55

Healthy Volunteers: Not accepted

Interventions

pyridostigmine

Placebo

Study Details

Brief summary:

This is a 3-day study comparing pyridostigmine versus placebo in the treatment of postural tachycardia syndrome (POTS). The researchers expect pyridostigmine to improve tachycardia and stabilize blood pressure.

Conditions

Postural Tachycardia Syndrome

Study ID

NCT00409435

Start date

Oct, 2006

Status verified date

Mar, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria:

Diagnosis of postural tachycardia syndrome using the following criteria:

  • Orthostatic heart rate increment greater than or equal to 30 beats per minute (bpm) within 5 minutes of head-up tilt.
  • Symptoms of orthostatic intolerance. These include weakness, lightheadedness, blurred vision, nausea, palpitations, and difficulty with concentration and thinking.

Both criteria must be fulfilled.

Exclusion Criteria:

  • Pregnant or lactating women
  • Presence of failure of other organ systems or systemic illness that could affect autonomic function or the patient's ability to cooperate with the study
  • Hypothyroidism or hyperthyroidism
  • Clinically significant coronary artery disease
  • Medications that could interfere with autonomic testing
  • Previous treatment with pyridostigmine for POTS. Patients must not have taken pyridostigmine in the past month

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: pyridostigmine

Active study drug

placebo comparator: Placebo

Control

Interventions

pyridostigmine

one 180 mg capsule per day for 3 days

Placebo

one capsule per day for 3 days

Primary outcome measure

  • Change in orthostatic symptoms using Composite Autonomic Symptom Scale (COMPASS) change [ Time Frame: 3 days ]

Central Contacts and Locations

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Toni Gehrking

507-284-0336adc.research@mayo.edu

Principal Investigator:

Wolfgang Singer, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Keywords

  • Postural tachycardia syndrome (POTS)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-03-05.