NCT00409435

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
9mo left

Started Oct 2006

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Oct 2006Feb 2027

Study Start

First participant enrolled

October 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 8, 2006

Completed
20.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

20.4 years

First QC Date

December 6, 2006

Last Update Submit

March 3, 2026

Conditions

Postural Tachycardia Syndrome

Keywords

Postural tachycardia syndrome (POTS)

Outcome Measures

Primary Outcomes (1)

  • Change in orthostatic symptoms using Composite Autonomic Symptom Scale (COMPASS) change

    3 days

Secondary Outcomes (2)

  • Heart rate response to head-up tilt

    3 days

  • Plasma norepinephrine change

    3 days

Study Arms (2)

pyridostigmine

ACTIVE COMPARATOR

Active study drug

Drug: pyridostigmine

Placebo

PLACEBO COMPARATOR

Control

Drug: Placebo

Interventions

pyridostigmineDRUG

one 180 mg capsule per day for 3 days

pyridostigmine
PlaceboDRUG

one capsule per day for 3 days

Placebo

Eligibility Criteria

Age15 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Related Publications (1)

  • Dani M, Fedorowski A. Tackling POTS Needs More Than Just a Sympathetic Approach. Hypertension. 2024 Nov;81(11):2248-2250. doi: 10.1161/HYPERTENSIONAHA.124.23716. Epub 2024 Oct 16. No abstract available.

    PMID: 39413203DERIVED

Related Links

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome

Interventions

Pyridostigmine Bromide

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Pyridinium CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Wolfgang Singer, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 6, 2006

First Posted

December 8, 2006

Study Start

October 1, 2006

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

March 5, 2026

Record last verified: 2026-03

Locations

US(1)