Pyridostigmine for Parkinson's Disease

Recruiting in Palo Alto (17 mi)

Overseen by Lisa M Deuel, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Vermont Medical Center

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Adults with Parkinson's Disease who suffer from chronic constipation can join this trial. They must be able to take oral meds, follow the study plan, and use effective birth control if of childbearing potential. Excluded are those with bowel surgery history, severe lung conditions, atypical parkinsonism forms, pyridostigmine allergy or recent use.

Inclusion Criteria

Be able to provide signed informed consent

Stated ability and willingness to comply with all study procedures

I agree to use effective birth control methods during and after the study.

Exclusion Criteria

I have been diagnosed with parkinsonism caused by medication.

I have had surgery on my intestines before.

Known allergy to pyridostigmine bromide or other study drug components

Participant Groups

The trial is testing Pyridostigmine Bromide's effectiveness and safety in treating constipation for Parkinson’s patients. It aims to find a dedicated treatment where none currently exists specifically for these individuals.

Group I: Pyridostigmine Bromide Experimental Treatment 1 Intervention

Open Label

Pyridostigmine Bromide is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Mestinon for:

• Myasthenia gravis
• Postoperative ileus (off-label)

🇪🇺 Approved in European Union as Mestinon for:

• Myasthenia gravis

🇨🇦 Approved in Canada as Mestinon for:

• Myasthenia gravis

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Vermont Medical Center Burlington, VT

Who Is Running the Clinical Trial?

University of Vermont Medical Center Lead Sponsor

References