Phase 4 Parkinson's Disease Trial, Not Yet Recruiting NCT07187466 Sponsor: VA Office of Research and Development Condition: Parkinson's Disease
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Phase 4 Parkinson's Disease Trial, Not Yet Recruiting

NCT07187466
Not Yet Recruiting Phase 4

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not 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 may be able to join

  • People who have been diagnosed with Parkinson's disease by a neurologist who specialises in movement disorders.
  • People who score 7 or higher on a bladder symptom questionnaire (called the ICIQ-OAB), meaning they experience significant overactive bladder symptoms such as sudden urges to urinate, needing to urinate frequently during the day, or waking at night to urinate, without these being caused by an infection or other clear condition.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People with significant memory or thinking difficulties, as shown by a score below 18 on a standard cognitive assessment (MoCA) or below 13 on a phone-based version of the same test.
  • People who have previously completed an intensive pelvic floor muscle exercise programme.
  • People with clinically significant depression, as shown by a score of 10 or higher on a short depression questionnaire (Geriatric Depression Scale-Short Form), which could affect the ability to fully participate in the programme.
  • People who currently use a catheter that stays inside the bladder (called an indwelling catheter).
  • People who have more than 150 mL of urine remaining in their bladder after urinating, as measured by an ultrasound scan.
  • People with severe uterine (womb) prolapse that extends outside the vaginal opening.
  • People with poorly controlled diabetes, defined as a blood sugar control measurement (HgbA1c) above 9.0% in the last 3 months — though the trial site may consider enrolling people if their bladder symptoms continue after diabetes control improves.
  • People with chronic kidney failure who are receiving dialysis treatment.
  • People with cancer of the urinary or genital organs who are currently undergoing surgery or external radiation treatment.
  • People who have previously had an artificial urinary sphincter, a bladder sling procedure, or a surgically implanted nerve stimulation device for bladder control.
  • People who have received botulinum toxin (Botox) injections into the bladder within the last 12 months.
  • People with any unstable health condition that the principal investigator expects could lead to hospitalisation or death within the next 3 months.
  • People with a known allergy or sensitivity to the class of medication being studied.
  • People for whom the study drug (mirabegron) is medically unsuitable, including those with a history of sudden, complete inability to urinate that required a catheter to relieve it.
  • People currently taking a bladder-relaxing medication — though the trial site may allow enrolment after a one-week period of stopping that medication.
  • People who have blood detected in their urine under microscopic examination, where no infection is present — enrolment would depend on review by a urology specialist and approval by the site's principal investigator (confirm with trial site).
  • People taking a water tablet (diuretic) whose dose has not been stable for at least 4 weeks.
  • People taking an alpha-blocker medication whose dose has not been stable for at least 4 weeks.
  • People taking dutasteride or finasteride whose dose has not been stable for at least 6 months.

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 8 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Elizabeth Camille Vaughan, MD MS, Atlanta VA Medical and Rehab Center, Decatur, GA

Phone: (404) 321-1611

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
Not Yet Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
1 July 2026
Est. completion
31 March 2030

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

ICIQ-OAB

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: 8 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