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Testing pyridostigmine for constipation

Researchers study the medicine pyridostigmine as a treatment for constipation in people with Parkinson’s.

Testing a treatment or activity · Study reference: NCT05603715

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

This registry record was last updated over six months ago, or its update date is missing. Recruitment may have changed. Confirm with the team before making plans.

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Looking for volunteers

Start (reported actual date)
2022-08-10
Main measurements finished (planned)
2026-12-31
Study finished (planned)
2026-12-31

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded
  • 2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.

Who can join?

Age 18 years and over · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

Inclusion Criteria: 1. Age ≥ 18 years 2. Be able to provide signed informed consent 3. Stated ability and willingness to comply with all study procedures 4. Able to take oral medications 5. Females of reproductive potential who are sexually active must be willing to use two of the following highly effective methods of contraception for the duration of study participation and for an additional 28 days after the end of study drug administration: barrier contraception (female condom, diaphragm, cervical cap with/without spermicide), hormonal contraception, or intrauterine device; OR one of the previously mentioned methods AND partner must use barrier contraception (male condom with/without spermicide) 6. Males of reproductive potential who are sexually active must be willing to use the following highly effective methods of contraception for the duration of study participation and for an additional 28 days after the end of study drug administration: barrier contraception (male condom with/without spermicide) AND partner must be postmenopausal, use hormonal contraception, have an intrauterine device, or use barrier contraception (female condom, diaphragm, cervical cap with/without spermicide) 7. Meet United Kingdom Parkinson's Disease Society Brain Bank Criteria: A. Diagnosis of a parkinsonism: * 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 B. At least three supportive criteria: * 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: i. Three or fewer defecations per week ii. Straining during \> 25% of defecations iii. Lumpy or hard stools in \> 25% of defecations iv. Sensation of incomplete evacuation for \> 25% of defecations v. Sensation of anorectal obstruction/blockage for \> 25% of defecations vi. Manual maneuvers to facilitate \> 25% of defecations * 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 Criteria: 1. Diagnosis of atypical parkinsonism 2. Diagnosis of drug-induced parkinsonism 3. Diagnosis of vascular parkinsonism 4. Known allergy to pyridostigmine bromide or other study drug components 5. Current or recent (within 90 days of enrollment) use of pyridostigmine for any reason 6. History of any bowel surgery 7. History of bladder or bowel obstruction 8. Severe asthma or chronic obstructive pulmonary disease 9. Meet exclusion criteria noted in the UK Parkinson's Disease Society Brain Bank Criteria, at the PI's discretion: A.Exclusion of any of the following: * 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
Full study name & original research details

Official study title

Pyridostigmine for the Treatment of Constipation in Parkinson Disease

Original description

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.

Further description from the registry

This is a 13-15 week open-label, dose escalation trial of pyridostigmine 60-180mg three times a day (TID) for the treatment of constipation in patients with Parkinson disease.

Conditions reported: Parkinson Disease; Constipation

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Interventional
Interventions
Pyridostigmine Bromide
Phases
PHASE2
Sponsor
University of Vermont Medical Center
Start date reported by registry
2022-08-10 (actual)

Registry updated: 2026-02-23 · Status last verified by the registry submitter: 2026-02

Registry records retrieved 2026-10-13 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Kaysi Herrera Pujols · (802) 847-4589 · Kaysi.HerreraPujols@uvmhealth.org

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

University of Vermont Medical Center

Burlington, Vermont, United States

Recruiting

Kaysi Herrera Pujols · 802-847-4589 · Kaysi.HerreraPujols@uvmhealth.org

Lisa Deuel, MD

Facility not reported

United States

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.