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Pyridostigmine for Constipation in Parkinson Disease

This study is testing Pyridostigmine Bromide, an oral tablet, to see if it can help treat constipation in people with Parkinson's disease. Constipation is a common problem for people with Parkinson's and can greatly affect their quality of life. Researchers want to find out if Pyridostigmine Bromide is effective and safe. You may be able to join if you are 18 years or older, can take oral medications, and are willing to follow all study procedures. The main goal is to see if the number of spontaneous bowel movements per week changes after taking the medication. This study plans to enroll 16 participants, but its current status is unclear.

Study design
This is an open-label study, meaning both you and the study team will know what medication you are receiving. It's a dose escalation trial, meaning the dose of Pyridostigmine Bromide will gradually increase. Sixteen participants are planned for this study.
What's involved
You would take Pyridostigmine Bromide oral tablets three times a day for four weeks. The total study participation will last between 13 and 15 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your number of spontaneous bowel movements will be measured at 13-15 weeks after starting the study intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05603715

Pyridostigmine for the Treatment of Constipation in Parkinson Disease

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Vermont Medical Center
~16 participants
Updated 2026-02-23 on ClinicalTrials.gov
What's tested:Pyridostigmine Bromide

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in number of spontaneous bowel movements per week after the study intervention
Measured over 13-15 Weeks

Conditions

Parkinson Disease
Constipation

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NCT05603715

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Vermont Medical Center

    Burlington, Vermontstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Lisa M Deuel, MD · PRINCIPAL_INVESTIGATOR · University of Vermont

Who to contact

Kaysi Herrera Pujols
[email protected]
(802) 847-4589
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Bradykinesia, plus at least one of the following:
Muscular rigidity
4-6 Hz resting tremor
Postural stability not caused by primary visual, vestibular, cerebellar or proprioceptive dysfunction
Unilateral onset of symptoms
Rest tremor
Progressive symptoms
Persistent asymmetry affecting the side of onset most
Excellent response to levodopa
Severe levodopa-induced chorea
Levodopa response for five years or more
Clinical course of 10 years or more 8. Fulfill the ROME IV Criteria for Functional Constipation, with a specific requirement that the patient must have three or fewer defecations per week (criterion Ai):
Must include two or more of the following:
Loose stools are rarely present without the use of laxatives
Insufficient criteria for irritable bowel syndrome
Criteria 1-3 must be fulfilled for at least three months with onset of symptoms at least six months prior to diagnosis

Exclusion

Repeated strokes with stepwise progression of parkinsonian features
Repeated head injury
Definite encephalitis
Oculogyric crises
Neuroleptic treatment at onset of symptoms
Greater than one affected relative
Sustained remission
Strictly unilateral features after 3 years
Supranuclear gaze palsy
Cerebellar signs
Early severe autonomic involvement
Early severe dementia
Babinski sign
Cerebral tumor or communicating hydrocephalus
Negative response to large doses of levodopa
1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine exposure 10. Significant abnormalities on laboratory analysis (complete blood count, comprehensive metabolic panel, thyroid stimulating hormone) conducted at the screening visit or within the three months prior if available for review 11. Significant abnormalities on screening electrocardiogram conducted at the screening visit or within the three months prior if available for review 12. Positive pregnancy test (if female of child-bearing age) 13. Antibiotic use within two weeks prior to enrollment

What this trial measures

  • Change in number of spontaneous bowel movements per week after the study intervention13-15 Weeks

    Participants will keep a Bowel Movement Journal during the four week Screening Phase, from which the pre-intervention average number of spontaneous bowel movements will be calculated. They will again keep a Bowel Movement Journal for the four weeks of the Treatment Phase, from which the postintervention average number of spontaneous bowel movements will be calculated.