16 Participants NeededMy employer runs this trial

Pyridostigmine for Parkinson's Disease

LM
KH
Overseen ByKaysi Herrera Pujols
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Vermont Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether pyridostigmine (known as Mestinon or Regonol) is a safe and effective treatment for chronic constipation in people with Parkinson's disease. Constipation is a common and challenging issue for those with Parkinson's, significantly affecting their quality of life. Participants must have Parkinson's disease and experience constipation, defined as having three or fewer bowel movements per week. This study could lead to better management options for those struggling with this condition. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you have used pyridostigmine in the last 90 days.

Is there any evidence suggesting that pyridostigmine bromide is likely to be safe for humans?

Research has shown that pyridostigmine bromide is generally safe for people. In studies with patients experiencing dizziness when standing, pyridostigmine caused few side effects. Another study found it safe for individuals with Parkinson's disease who experienced drops in blood pressure, helping manage symptoms without major side effects. The FDA has also approved pyridostigmine for treating myasthenia gravis, a condition that causes muscle weakness, indicating a known safety record. Overall, research suggests pyridostigmine is safe to use, but individual experiences may vary.12345

Why do researchers think this study treatment might be promising for Parkinson's?

Pyridostigmine Bromide is unique because it targets Parkinson's disease by enhancing communication between nerves and muscles, which is different from most current treatments like Levodopa and dopamine agonists that primarily focus on boosting dopamine levels in the brain. This approach could offer an alternative pathway to alleviate symptoms without relying solely on dopamine. Researchers are excited about Pyridostigmine Bromide because it offers a new mechanism of action and may help address symptoms that are less responsive to traditional dopamine-based therapies.

What evidence suggests that pyridostigmine might be an effective treatment for constipation in Parkinson's disease?

Research has shown that pyridostigmine, a drug for myasthenia gravis, helps the intestines move more efficiently, potentially relieving constipation. However, some studies suggest it might also cause diarrhea and stomach cramps due to this effect. Among patients with myasthenia gravis, most reported a satisfaction score of 60 out of 100 and a benefit score of 65, indicating positive experiences. Although data on pyridostigmine's effectiveness for constipation related to Parkinson's disease is limited, its ability to improve gut movement offers hope for relieving this symptom in Parkinson's patients. Participants in this trial will receive pyridostigmine bromide to evaluate its potential benefits for constipation in Parkinson's disease.25678

Who Is on the Research Team?

LM

Lisa M Deuel, MD

Principal Investigator

University of Vermont

Are You a Good Fit for This Trial?

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.
See 4 more

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
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks
1 visit (in-person)

Treatment

Participants receive pyridostigmine 60-180mg three times a day for constipation treatment

9-11 weeks
Regular visits for dose escalation and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Pyridostigmine Bromide

Trial Overview

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.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Pyridostigmine BromideExperimental Treatment1 Intervention

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

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Approved in United States as Mestinon for:
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Approved in European Union as Mestinon for:
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Approved in Canada as Mestinon for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Vermont Medical Center

Lead Sponsor

Trials
46
Recruited
25,900+

Citations

Pyridostigmine for the Treatment of Constipation in ...

The goal of this study is to determine the efficacy and safety of pyridostigmine as a treatment for chronic constipation in patients with PD.

Pyridostigmine Bromide and Constipation in Parkinson's ...

This drug, which is used in the treatment of myasthenia gravis, enhances intestinal motility and may in fact produce diarrhea and abdominal cramps in some ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/28224720/

Pyridostigmine bromide versus fludrocortisone in the ...

Pyridostigmine bromide is inferior to fludrocortisone in the treatment of OH in PD. This trial provides first objective evidence of the efficacy of 0.2 mg/day ...

Pyridostigmine for the Treatment of Constipation in ...

The goal of this study is to determine the efficacy and safety of pyridostigmine as a treatment for chronic constipation in patients with PD.

The effectiveness and side effects of pyridostigmine in ...

Patients reported a median effectiveness of 60, IQR 28-78 and net benefit of 65, IQR 45-84. Of all patients currently using pyridostigmine, 91% reported side ...

Pyridostigmine in the management of orthostatic hypotension

In most studies, pyridostigmine had no significant effect on supine BP. Adverse effects were minimal across the included studies. The pooled ...

Preliminary Observations from Acetylcholine Esterase ...

Pyridostigmine use was also associated with improvement in standing heart rate (98 at baseline, 86 at 3 months and 72 at 6 month and systolic blood pressure (95 ...

What is the role of Pyridostigmine (Mestinon) in Parkinson's ...

Pyridostigmine may be beneficial in patients with Parkinson's Disease (PD) who experience syncope due to neurogenic orthostatic hypotension ...