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A Study of Pyridostigmine in Postural Tachycardia Syndrome

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Notable

    Primary and study completion dates: Feb 2026 to Feb 2027

    Study Statusv30

  2. Minor

    Site contact updated

    Study Status, Sponsor/Collaborators, Contacts/Locationsv29

  3. Notable

    Primary and study completion dates: Feb 2025 to Feb 2026

    Study Statusv28

  4. Notable

    Primary and study completion dates: Feb 2024 to Feb 2025

    Study Statusv27

  5. Notable

    Phase: Not applicable to Phase 2

    Primary and study completion dates: Feb 2023 to Feb 2024; Collaborator revised

    Show what changed: Collaborators
    National InstitutesInstitute of HealthNeurological Disorders and Stroke (NIHNINDS)

    Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Designv26

Show 24 earlier versions

  1. Notable

    Primary and study completion dates: Feb 2022 to Feb 2023

    Study Statusv25

  2. Notable

    Primary and study completion dates: Feb 2021 to Feb 2022

    Study Statusv24

  3. Notable

    Primary and study completion dates: Feb 2020 to Feb 2021

    Study Statusv23

  4. Notable

    Primary and study completion dates: Feb 2019 to Feb 2020

    Study Status, Referencesv22

  5. Minor

    Study Status

    Re-verified, no change to tracked fields

    v21

  6. Notable

    Primary and study completion dates: Feb 2017 to Feb 2019

    Study Statusv20

  7. Notable

    Primary and study completion dates: Feb 2016 to Feb 2017

    Study Statusv19

  8. Minor

    Study Status

    Re-verified, no change to tracked fields

    v18

  9. Notable

    Primary and study completion dates: Feb 2015 to Feb 2016

    Study Statusv17

  10. Minor

    Study Status

    Re-verified, no change to tracked fields

    v16

  11. Notable

    Trial status: Active, Not Recruiting to Recruiting

    Site details revised

    Study Status, Contacts/Locationsv15

  12. Notable

    Primary and study completion dates: Oct 2013 to Feb 2015

    Study Statusv14

  13. Notable

    Primary and study completion dates: Oct 2012 to Oct 2013

    Study Statusv13

  14. Minor

    Trial status: Recruiting to Active, Not Recruiting

    Site details revised

    Study Status, Contacts/Locationsv12

  15. Notable

    Primary and study completion dates: Oct 2011 to Oct 2012

    Study Status, Sponsor/Collaboratorsv11

  16. Minor

    Study Status

    Re-verified, no change to tracked fields

    v10

  17. Notable

    Primary and study completion dates: Oct 2010 to Oct 2011

    Study Statusv9

  18. Minor

    Study Status

    Re-verified, no change to tracked fields

    v8

  19. Minor

    Interventions: pyridostigmine (Drug) to Placebo (Drug), pyridostigmine (Drug)

    Secondary endpoints: details revised at 2 of 2 entries; Study arms: 0 to 2

    Study Status, Arms and Interventions, Outcome Measuresv7

  20. Minor

    Primary completion date: Oct 2010

    Completion date: Oct 2009 to Oct 2010

    Study Status, Sponsor/Collaborators, Oversight, Study Designv6

  21. Minor

    Eligibility criteria expanded, about 16 words

    Study description shortened, about 34 words

    Show what changed: Eligibility criteria
    [...] ease Medications that could interfere with autonomic testing Previous treatment with pyridostigmine for POTS. Patients must not have taken pyridostigmine in the past month
    Show what changed: Study description
    [...] arch Center (GCRC) at Charlton 7 and will involve two visits and one telephone interview. Visit 1 will take about 3 hours, the telephone interview will occur 4 weeks after Visit 1 and will take about 5 minutes, and Visit 2 will occur 82 weeksdays after Visit 1 and will take about 2 hours. You will be put [...] look identical and will be taken as one capsule per day for 83 weeksdays. Neither you nor the study doctor will know at the time of [...] tiredness, cold and sweaty hands) at each of your two visits and via mail at the 4-week time point. The questionnaire you will be given during your first visi [...] 30 [...]

    Study Status, Study Description, Study Design, Eligibilityv5

  22. Minor

    Eligibility criteria revised

    Show what changed: Eligibility criteria
    Inclusion Criteria: Diagnosis of postural tachycardia syndrome using the follow [...] hinking. Both criteria must be fulfilled. Exclusion Criteria: Pregnant or lactating women Presence of failure of other or [...]

    Study Status, Eligibilityv4

  23. Notable

    Primary endpoint revised

    Eligibility criteria expanded, about 3 words

    Show what changed: Primary endpoints
    Change in orthostatic symptoms using Composite Autonomic Symptom Scale (COMPASS) change
    Show what changed: Eligibility criteria
    [...] rthostatic heart rate increment greater than or equal to 30 beats per minute (bpm) within 5 minutes of head-up tilt. Symptoms of orthostatic i [...] kness, lightheadedness, blurred vision, nausea, palpitations, and difficulty with concentration and thinking. Both criter [...]

    Study Status, Study Description, Conditions, Outcome Measures, Eligibilityv3

  24. Minor

    Eligibility criteria expanded, about 56 words

    Site contact updated; Study title shortened, about 1 word

    Show what changed: Eligibility criteria
    Inclusion Criteria Diagnosis of postural tachycardia syndrome using the following criteria: Orthostatic heart rate increment greater than or equal to 30 [...] 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 c [...]
    Show what changed: Study title
    Double-Blind, Placebo-ControlledA Study of Pyridostigmine in Postural Tachycardia Syndrome

    Study Identification, Study Status, Eligibility, Contacts/Locationsv2

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Mayo Clinic
1,019 trials monitored
See 123 trials at risk
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 Details
NCT Number NCT00409435
Lead Sponsor Mayo Clinic
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Conditions Postural Tachycardia Syndrome
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov