Early Phase 1 Parkinson's Disease Trial, Not Yet Recruiting NCT07533591 Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University Condition: Parkinson's Disease
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Early Phase 1 Parkinson's Disease Trial, Not Yet Recruiting

NCT07533591
Not Yet Recruiting Early Phase 1

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 aged between 40 and 70 years (inclusive), of any gender
  • People who have been diagnosed with primary Parkinson's disease rated at a severe level (H&Y grade 4 or 5)
  • People whose Parkinson's disease was diagnosed at least 5 years ago
  • People whose symptoms have responded to levodopa (a common Parkinson's medication) for at least 12 months
  • People whose motor symptom severity score on a standard Parkinson's assessment (MDS-UPDRS Part III) is 35 or higher
  • People whose symptoms improve by at least 30% on a standard medication response test (the Madopar challenge test)
  • People whose symptoms and medications have been stable for at least 4 weeks before the screening visit
  • People who are able to understand the study and are willing to sign a consent form
  • People who agree to delay any brain surgery, including deep brain stimulation, until after the 12-month follow-up period is complete
  • People whose Parkinson's medications have become significantly less effective, or who have developed notable movement-related side effects, or who experience severe side effects from their current medications
  • People who have not had a bad reaction to a prescribed dose of olanzapine (a medication used in the study)
  • People who are willing and able to attend all follow-up visits as required by the study

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 who have previously had brain surgery for Parkinson's disease, such as deep brain stimulation, or who have unusual findings on a brain scan
  • People who score 20 or higher on the Hamilton Depression Scale (a standard measure of depression severity)
  • People who score 14 or higher on the Hamilton Anxiety Scale (a standard measure of anxiety severity)
  • People with a history of brain injury or infection affecting the brain or nervous system
  • People with significant cognitive impairment, indicated by scoring below 26 on the MoCA test or 20 or below on the MMSE test
  • People with weakness, numbness, or other neurological symptoms affecting one part of the body (focal neurological deficits)
  • People with a significant medical or mental health condition, such as dementia, psychosis, a history of substance misuse, or severe depression
  • People whose Parkinson's disease is considered atypical or caused by something other than primary Parkinson's disease, such as a head injury, brain tumour, infection, stroke, another neurological condition, or exposure to certain drugs, chemicals, or toxins
  • People who have previously received gene therapy or cell therapy
  • People with a history of cancer, not including certain treated early-stage cancers, or who have poorly controlled medical conditions that could increase surgical risk
  • People with a history of stroke, significant heart or blood vessel disease, or diabetes
  • People with an active infection detected either by symptoms or laboratory tests
  • People currently receiving long-term treatments that suppress the immune system, including ongoing steroids, immunotherapy, chemotherapy, or cytotoxic therapy
  • People with blood clotting disorders, or who are unable to temporarily stop blood-thinning or antiplatelet medications before surgery
  • People with severe liver disease, indicated by liver enzyme levels (AST/ALT) at 2.5 times or more above the normal upper limit
  • People who have medical, social, or practical circumstances (such as living far from the trial site) that may make it difficult to follow the study requirements
  • People whom the trial investigators consider unsuitable for any other reason

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 23 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Principal Investigator: Jiali Pu, Second Affiliated Hospital, School of Medicine, Zhejiang University

Phone: +86-13989468062

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
Early Phase 1
Registry
ClinicalTrials.gov
Start date
1 May 2026
Est. completion
1 April 2029

Where this trial is recruiting

🇨🇳 China

Primary endpoints

The incidence rates of adverse events and serious adverse events within 3 months after injecting STP-001 into the bilateral subthalamic nuclei.

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: 23 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