Phase 4 Parkinson's Disease Trial, Recruiting NCT07138560 Sponsor: The Cleveland Clinic Condition: Parkinson's Disease
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Phase 4 Parkinson's Disease Trial, Recruiting

NCT07138560
Recruiting Phase 4

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 who are 40 years of age or older
  • People who have been diagnosed with idiopathic Parkinson's disease (Parkinson's that does not have a known cause) and whose symptoms respond to the medication levodopa
  • People whose Parkinson's symptom severity score (measured by a standard scale called MDS-UPDRS) is above 20 when measured in an "off" state — meaning when medication effects have worn off
  • People who have been on a stable dose of a carbidopa-levodopa (CD-LD) medication for at least four weeks
  • People whose levodopa dose falls within certain ranges — the minimum single dose is 100 mg for immediate-release CD-LD or 195 mg for the extended-release form called Rytary; the maximum daily dose is 1,200 mg for immediate-release CD-LD, 1,000 mg when taken alongside a COMT inhibitor (a type of add-on medication), or 2,400 mg for Rytary (confirm with trial site)
  • People who have been on stable doses of any additional Parkinson's or mental health medications for at least 30 days
  • People who experience at least 2 hours per day of "off time" (periods when medication is not working well enough) and who are able to wear a movement-tracking wristband device

Who may not be able to join:

  • People with severe involuntary movements (called dyskinesia), defined as the highest possible score on a specific question in a standard Parkinson's rating scale measuring how much time is spent with these movements
  • People currently using device-based treatments for advanced Parkinson's disease, such as deep brain stimulation or a medication pump
  • People using a controlled-release form of carbidopa-levodopa, except for a single dose taken at bedtime
  • People using "on demand" or as-needed Parkinson's medication who are not willing to stop taking it for the duration of the study
  • People who have been diagnosed with, or show signs of, dopamine dysregulation syndrome, or who have significant levodopa-related complications such as a drop in blood pressure when standing (orthostatic hypotension) or psychosis
  • People with a history of dementia, or who score below 23 on a standard memory and thinking test called the MoCA
  • People with other significant medical conditions that may interfere with taking part in the study (confirm with trial site)
  • People who are currently enrolled in another clinical trial that involves taking an active medication

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 14 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: Hubert Fernandez, MD, The Cleveland Clinic

Phone: 216 678-8896

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 4
Registry
ClinicalTrials.gov
Start date
24 July 2025
Est. completion
15 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Primary Endpoint

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: 14 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