Pyridostigmine for the Treatment of Constipation in Parkinson Disease
University of Vermont Medical Center
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.
Description
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 p…
Interventions
- DrugPyridostigmine Bromide
Dose escalation trial of Pyridostigmine bromide oral tablets 60-180 mg TID for four weeks
Location
- University of Vermont Medical CenterBurlington, Vermont