Early Phase 1 Parkinson's Disease Trial, Not Yet Recruiting
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 clinically diagnosed with idiopathic (primary) Parkinson's Disease, based on recognised Chinese (2016) or international MDS (2015) diagnostic guidelines.
- People between the ages of 40 and 65 (inclusive), of any gender.
- People who have had Parkinson's Disease for 5 years or more.
- People whose disease severity, measured during an "off" period (when medication is less effective), falls within a specific range on the Hoehn-Yahr staging scale (2.5 to 4).
- People who have been regularly taking dopaminergic medications, including levodopa for at least 4 weeks before the screening period.
- People whose motor symptoms score above 35 on a standard assessment scale (MDS-UPDRS III) during an "off" period, and whose symptoms improve by at least 30% after a test dose of levodopa.
- People whose blood test shows an AAV neutralising antibody level at or below 1:2000 (confirm with trial site).
- People who agree to delay any other brain or nerve surgery (except in a life-threatening emergency) during the main study period.
- People who have completed a 1-month observation period showing no serious reactions to a planned dose of clozapine (a medication used in the trial).
- People who agree not to take part in any other treatment-based research studies during the trial.
- People who agree not to receive any vaccines during the study period.
- People who are willing to use reliable contraception from the screening period until at least 8 weeks after the study drug is given.
- People who are able to attend regular follow-up appointments and accurately complete a daily Parkinson's diary, with help from a family member, carer, or guardian if needed.
- People who fully understand the trial's purpose, methods, and potential risks, and who voluntarily sign a consent form (a legal representative or witness may assist if the person is unable to read).
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 an atypical or secondary form of Parkinsonism, such as Parkinson's-plus syndrome, hereditary Parkinson's, or drug-induced Parkinson's syndrome.
- People who have a medical reason preventing surgery, or who have previously had deep brain stimulation, pallidotomy, or other brain surgeries that the researchers determine would affect participation.
- People whose prior brain scans show structural brain abnormalities, blood vessel malformations, brain tumours, bleeding risk, brain injury, or other significant abnormalities.
- People who score below 24 on the Mini-Mental State Examination (MMSE), a standard memory and thinking test.
- People who score below 26 on the Montreal Cognitive Assessment (MoCA), another standard thinking and memory test.
- People who score 16 or above on the PHQ-9 depression questionnaire, suggesting significant depression.
- People with abnormal liver or kidney function based on blood test results above specific thresholds.
- People with abnormal blood clotting function or who are currently taking blood-thinning medications.
- People who test positive for Hepatitis B, Hepatitis C, HIV, or syphilis.
- People who are currently receiving antiviral treatment for Hepatitis B or Hepatitis C.
- People with unstable or serious other medical conditions, including active tuberculosis, or significant heart, lung, digestive, kidney, mental, blood, or immune system disease, where the researchers determine participation is not appropriate.
- People who have or have had a malignant (cancerous) tumour.
- People who have had a severe allergic reaction in the past, are allergic to contrast dye, or cannot tolerate surgical anaesthesia.
- People who are currently in another clinical trial or who have participated in one within the 3 months before screening.
- People who have previously received gene therapy.
- People who have received stem cell therapy within 6 months before the screening period.
- People who have taken another experimental drug within 4 weeks before screening, or within 5 half-lives of that drug (whichever is longer), or any drug the researchers determine could affect this trial.
- People who received a live vaccine within 2 months before screening, or any vaccine within 30 days before screening.
- People with a history of alcohol or drug dependence who are unable to stop drinking as advised during the trial.
- Women who are pregnant or breastfeeding.
- People who have developed severe movement complications from Parkinson's medications and for whom no suitable alternative treatment is available.
- People whom the researchers assess as otherwise unsuitable for 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.
Contact this trial
Phone: 15221303819
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
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Where this trial is recruiting
Primary endpoints
1. The incidence of adverse events and serious adverse events within 12 months after bilateral subthalamic nucleus injection of STP-001, which is the adeno-associated virus vector carrying the target gene.; 2. The changes in the titer levels of the binding and capsid-neutralizing antibodies against adeno-associated virus in serum within 12 months after bilateral subthalamic nucleus injection of STP-001.
Can't join this trial?
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.