Parkinson's Disease Trial, Recruiting NCT07330258 Sponsor: Bayer Condition: Parkinson's Disease
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Parkinson's Disease Trial, Recruiting

NCT07330258
Recruiting Not Applicable

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 45 to 75 years old (and at least 30% of participants enrolled must be aged 60 or younger).
  • People who have been diagnosed with Parkinson's disease, according to recognised medical criteria, for at least 4 years but no more than 12 years at the time of joining the trial.
  • People whose Parkinson's symptoms are rated as moderate in severity (Stage II or III on a standard scale) when assessed after being off their Parkinson's medications for at least 12 hours.
  • People whose movement symptoms score 30 or higher on a standard Parkinson's disease rating scale when assessed off medication.
  • People who experience at least 1 hour per day where their Parkinson's medications are not working well enough (known as "off" time), as assessed by their doctor or themselves.
  • People who have been on a stable Parkinson's medication routine for at least 4 weeks before screening, taking a daily levodopa dose of at least 300 mg or taking it 3 or more times per day.
  • People whose movement symptoms clearly improve after taking their usual morning dose of Parkinson's medication (confirm with trial site for the specific improvement thresholds required).
  • People who score 24 or higher on a standard memory and thinking assessment.
  • People who agree to take part and sign a consent form.

Care partners may also be enrolled:

  • Adults aged 18 or older who have been identified by the Parkinson's patient as their main care partner, and who are able to consent independently.

Who may not be able to join:

  • People who have, or are suspected to have, a condition that could explain their symptoms instead of Parkinson's disease — such as multiple system atrophy, progressive supranuclear palsy, vascular Parkinsonism, Lewy body dementia, Huntington's disease, Alzheimer's disease, or other similar conditions.
  • People with a history of significant vascular or heart-related conditions, including stroke, mini-strokes (TIAs), poorly controlled high blood pressure or diabetes, or unstable heart conditions.
  • People with a significant history of psychosis, impulse control disorder, or depression that is untreated or not well managed.
  • People with a known history of HIV, hepatitis B, hepatitis C, syphilis, or tuberculosis.
  • People who have had an active cancer diagnosis in the past 5 years (some fully treated skin cancers or cervical carcinoma in situ may be exceptions — confirm with trial site).
  • People who are currently pregnant, breastfeeding, or planning to become pregnant during the study.
  • People currently using or who have previously used certain advanced levodopa or apomorphine delivery systems (such as an intestinal gel pump or subcutaneous pump).
  • People who have previously had brain surgery, including deep brain stimulation, pallidotomy, focused ultrasound, or other experimental neurosurgical procedures.
  • People who have previously had or are currently undergoing cell or gene therapy.
  • People currently participating in another interventional clinical 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 21 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: (+)1-888-84 22937

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

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Registry
ClinicalTrials.gov
Start date
22 July 2026
Est. completion
21 December 2032

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Descriptive summary of motor outcomes among Parkinson's disease patients treated with oral antiparkinsonian medications who experience motor complications.; Descriptive summary of non-motor outcomes among Parkinson's disease patients treated with oral antiparkinsonian medications who experience motor complications.; Descriptive summary of Parkinson's medications and treatments received; Descriptive summary on the burden of care - psychological dimension; Descriptive summary on the burden of care - economic dimension

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: 21 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