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Could a nerve drug ease Parkinson's gut troubles?

NCT ID NCT05603715

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether pyridostigmine, a drug that stimulates the gut, can safely relieve chronic constipation in people with Parkinson's disease. Constipation is a common and bothersome symptom that often appears years before movement problems. Sixteen adults with Parkinson's will take the drug for four weeks and record their bowel movements to see if it helps.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 16 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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Contacts and locations

Locations

  • University of Vermont Medical Center

    RECRUITING

    Burlington, Vermont, 05401, United States

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Other studies related to the condition(s) this trial covers.