Pyridostigmine for the Treatment of Constipation in Parkinson Disease

NCT05603715 | Recruiting Phase 2 FDA Drug

• 1 other identifier: STUDY00001877
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Constipation; Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Change in number of spontaneous bowel movements per week after the study intervention

  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.

  13-15 Weeks

Secondary Outcomes (7)

• Changes from Baseline to the End of Study Visit in the Gastrointestinal Dysfunction Scale in Parkinson's Disease (GIDS-PD)

  9-11 Weeks

• Changes from Baseline to the End of Study Visit in the Cleveland Clinic Constipation Scoring System (CCCSS)

  9-11 Weeks

• Changes from Baseline to the End of Study Visit in the MDS-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-IV

  9-11 Weeks

• Changes from Baseline to the End of Study Visit in the International Parkinson and Movement Disorder Society Non-Motor Rating Scale (MDS-NMS)

  9-11 Weeks

• Changes from Baseline to the End of Study Visit in the Parkinson's Disease Questionnaire (PDQ-39).

  9-11 Weeks

Study Arms (1)

Pyridostigmine Bromide

OTHER

Open Label

Drug: Pyridostigmine Bromide

Interventions

Pyridostigmine Bromide DRUG

Dose escalation trial of Pyridostigmine bromide oral tablets 60-180 mg TID for four weeks

Pyridostigmine Bromide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Be able to provide signed informed consent
• Stated ability and willingness to comply with all study procedures
• Able to take oral medications
• 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)
• 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)
• 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
• 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

You may not qualify if:

• Diagnosis of atypical parkinsonism
• Diagnosis of drug-induced parkinsonism
• Diagnosis of vascular parkinsonism
• Known allergy to pyridostigmine bromide or other study drug components
• Current or recent (within 90 days of enrollment) use of pyridostigmine for any reason
• History of any bowel surgery
• History of bladder or bowel obstruction
• Severe asthma or chronic obstructive pulmonary disease
• 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

Sponsors & Collaborators

• University of Vermont Medical Center: lead

Study Sites (1)

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Constipation

Interventions

Pyridostigmine Bromide

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyridinium Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Lisa M Deuel, MD

  University of Vermont

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaysi Herrera Pujols

CONTACT

(802) 847-4589; Kaysi.HerreraPujols@uvmhealth.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: November 3, 2022
• Study Start: August 10, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

US (1)