Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05603715

Pyridostigmine for the Treatment of Constipation in Parkinson Disease

Led by University of Vermont Medical Center · Updated on 2026-02-23

16

Participants Needed

1

Research Sites

229 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Constipation is a common and debilitating non-motor symptom of Parkinson disease (PD) that often precedes the onset of classic motor symptoms by decades. There is no standardized algorithm for managing constipation in this patient population, nor are there dedicated treatments. Studies suggest that constipation can affect quality of life to a significant degree, in many cases just as much as motor symptoms. There is an unmet need for effective treatment options for constipation in this patient population. The goal of this study is to determine the efficacy and safety of pyridostigmine as a treatment for chronic constipation in patients with PD.

CONDITIONS

Official Title

Pyridostigmine for the Treatment of Constipation in Parkinson Disease

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Ability to provide signed informed consent
  • Willingness and ability to follow all study procedures
  • Ability to take oral medications
  • Females of reproductive potential who are sexually active must use two highly effective contraception methods during and 28 days after treatment, or one method plus partner use of barrier contraception
  • Males of reproductive potential who are sexually active must use barrier contraception during and 28 days after treatment, and partner must use effective contraception
  • Meet UK Parkinson's Disease Society Brain Bank Criteria for parkinsonism diagnosis
  • Meet ROME IV Criteria for Functional Constipation, including three or fewer defecations per week and related symptoms for at least three months, with onset at least six months before diagnosis
Not Eligible

You will not qualify if you...

  • Diagnosis of atypical, drug-induced, or vascular parkinsonism
  • Known allergy to pyridostigmine bromide or study drug components
  • Current or recent (within 90 days) use of pyridostigmine
  • History of bowel surgery
  • History of bladder or bowel obstruction
  • Severe asthma or chronic obstructive pulmonary disease
  • Exclusion criteria from UK Parkinson's Disease Society Brain Bank Criteria at investigator discretion, including repeated strokes, head injury, encephalitis, neuroleptic treatment at symptom onset, and others
  • Significant abnormalities in laboratory tests within three months before screening
  • Significant abnormalities on screening electrocardiogram within three months before screening
  • Positive pregnancy test for females of childbearing age
  • Antibiotic use within two weeks before enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Vermont Medical Center

Burlington, Vermont, United States, 05401

Actively Recruiting

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Research Team

K

Kaysi Herrera Pujols

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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