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Cholinesterase Inhibitor
Pyridostigmine for Parkinson's Disease
Phase 2
Recruiting
Led By Lisa M Deuel, MD
Research Sponsored by University of Vermont Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13-15 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial studies if pyridostigmine can help with constipation in people with Parkinson's Disease, as constipation can severely impact quality of life.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not explicitly listed here, common side effects of Pyridostigmine may include muscle cramps or twitching, changes in heart rate, pressure or pain in the stomach area, nausea or vomiting among others.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 13-15 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13-15 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Defecation
Secondary study objectives
Changes from Baseline to the End of Study Visit in Beck Depression Inventory-II (BDI-II)
Constipation
Parkinson Disease
+4 moreSide effects data
From 2016 Phase 4 trial • 87 Patients • NCT023081243%
Headache
3%
dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Midodrine Only
Midodrine + Pyridostigmine
Pyridostigmine Only
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pyridostigmine BromideExperimental Treatment1 Intervention
Open Label
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pyridostigmine Bromide
2002
Completed Phase 4
~590
Find a Location
Who is running the clinical trial?
University of Vermont Medical CenterLead Sponsor
42 Previous Clinical Trials
25,829 Total Patients Enrolled
Lisa M Deuel, MDPrincipal InvestigatorUniversity of Vermont
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with parkinsonism caused by medication.I have had surgery on my intestines before.I have been diagnosed with vascular parkinsonism.I agree to use effective birth control methods during and after the study.I have been diagnosed with a rare form of Parkinson's disease.I have severe asthma or COPD.I have had a blockage in my bladder or intestines.I can take pills by mouth.I am 18 years old or older.I have used pyridostigmine in the last 90 days.I am using two effective birth control methods during and 28 days after the study.I have been diagnosed with Parkinson's disease according to specific criteria.I don't have conditions that could be confused with Parkinson's or affect my eligibility.I have had constipation symptoms for over 3 months, with less than 3 bowel movements a week.
Research Study Groups:
This trial has the following groups:- Group 1: Pyridostigmine Bromide
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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