Phase 2 Parkinson's Disease Trial, Recruiting NCT05603715 Sponsor: University of Vermont Medical Center Condition: Parkinson's Disease
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Phase 2 Parkinson's Disease Trial, Recruiting

NCT05603715
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 or older.
  • People who are able to give signed consent to participate.
  • People who are willing and able to follow all study procedures throughout the trial.
  • People who are able to swallow and take tablets or capsules by mouth.
  • Women who could become pregnant and are sexually active must be willing to use two forms of highly effective contraception (such as condoms, diaphragm, hormonal contraception, or an intrauterine device) for the full duration of the trial and for 28 days after finishing the study medication.
  • Men who could father a child and are sexually active must be willing to use a male condom, and their partner must also use an effective contraceptive method (such as hormonal contraception, an intrauterine device, or a barrier method) for the full duration of the trial and for 28 days after finishing the study medication.
  • People who have been diagnosed with Parkinson's disease according to established UK diagnostic criteria, which includes slowness of movement plus at least one of: muscle stiffness, a specific type of resting tremor, or balance problems — along with at least three additional supporting features such as symptoms starting on one side of the body, a strong response to a medication called levodopa, or symptoms that have progressed over time.
  • People who have been diagnosed with functional constipation under recognised international criteria, which specifically requires having three or fewer bowel movements per week, plus at least one other constipation symptom (such as straining, hard stools, a feeling of incomplete emptying, a sense of blockage, or needing to use manual methods to pass a stool), with these symptoms present for at least three months and starting at least six months before diagnosis.

Who may not be able to join:

  • People diagnosed with an atypical form of parkinsonism (a related but different condition).
  • People whose parkinsonism is caused by medication.
  • People whose parkinsonism is caused by problems with blood flow to the brain (vascular parkinsonism).
  • People with a known allergy to pyridostigmine bromide or any other ingredient in the study drug.
  • People who have used pyridostigmine for any reason within the 90 days before enrolling.
  • People who have had any bowel surgery at any point in their life.
  • People who have a history of bladder or bowel obstruction.
  • People with severe asthma or severe chronic lung disease (COPD).
  • People whose medical history includes features that, in the opinion of the trial doctor, rule out a Parkinson's disease diagnosis under UK Brain Bank Criteria — such as a history of repeated strokes or head injuries, a history of encephalitis, certain eye movement problems, use of antipsychotic medication at the time symptoms began, more than one affected family member, periods of full recovery, specific neurological signs, early severe memory problems, a tumour in the brain, no response to high doses of levodopa, or exposure to a specific toxic substance known as MPTP (confirm with trial site).
  • People with significant abnormal results on blood tests (such as full blood count, metabolic panel, or thyroid hormone levels) taken at the screening visit or within the previous three months.
  • People with significant abnormal results on a heart tracing (ECG) taken at the screening visit or within the previous three months.
  • Women of childbearing age who have a positive pregnancy test.
  • People who have taken antibiotics within two weeks before enrolling in the trial.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Lisa M Deuel, MD, University of Vermont

Phone: (802) 847-4589

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
University of Vermont Medical Center
Registry
ClinicalTrials.gov
Start date
10 August 2022
Est. completion
31 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

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

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov