Phase 2 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 are between 45 and 75 years old at the time of signing the consent form.
- People who were diagnosed with Parkinson's disease (PD) more than 10 years before joining the trial.
- People who have slowness of movement (bradykinesia) plus at least one of the following: muscle stiffness, a tremor at rest, or problems with balance and posture.
- People whose Parkinson's symptoms are rated as moderately to severely limiting movement on a standard staging scale (Modified Hoehn and Yahr stage III or IV), measured when Parkinson's medication has worn off.
- People whose movement symptoms score above 40 on a standard Parkinson's rating scale (MDS-UPDRS Part III), measured when Parkinson's medication has worn off.
- People who have been on a stable Parkinson's medication routine for at least 4 weeks before the first screening visit, continuing through the baseline visit.
- People whose movement symptoms improve by 30% or more on the standard rating scale after taking a levodopa dose during a test.
- People who agree to use barrier-method contraception (such as condoms) during any sexual activity with another person for at least 3 months after receiving the study treatment.
- Male participants who agree not to donate sperm for at least 3 months after receiving the study treatment.
- Female participants who are not pregnant or breastfeeding at screening; women who could become pregnant must have a negative pregnancy test at required points during the study.
- People who sign the informed consent form, agreeing to follow all study requirements and restrictions.
- People who also give signed consent to participate in a related long-term follow-up study (ASK-PD0-CS002).
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 whose movement symptoms are caused by a different or atypical form of parkinsonism, as determined by a neurologist.
- People who have, or have had, psychosis or a disorder involving difficulty controlling impulses, as determined by a neurologist.
- People who have, or have had in the past 2 years, a substance use disorder (including alcohol), as defined by standard diagnostic criteria or in the judgment of a neurologist.
- People who have depression that is untreated or not well managed, as indicated by a score of 20 or higher on a standard depression questionnaire (BDI-II).
- People who are currently having thoughts of suicide (as shown by specific responses on a standard scale called the C-SSRS), or who have ever attempted suicide.
- People who have significant cognitive (thinking and memory) difficulties, as shown by a score below 25 on a standard cognitive test (MoCA).
- People who have, or have had, any cancer, other than certain treated skin cancers (squamous cell or basal cell carcinomas).
- People who currently have an active infection of any kind, including any infection on or around the scalp (either short-term or ongoing).
- People who cannot have an MRI scan for any known medical reason.
- People who have, or have had, significant problems with blood vessels in the brain or heart, including: a stroke, mini-stroke, or suspected stroke within the past year; unstable chest pain or a heart attack within the past year; a procedure to open or bypass blocked blood vessels within the past year; poorly controlled high blood pressure; poorly controlled diabetes or pre-diabetes with known blood vessel damage; or other significant heart or blood vessel history or risk factors.
- People who have a known history of complications with anaesthesia, such as difficulty with airway management or breathing tubes, a condition called malignant hyperthermia, or other issues that could make general anaesthesia unsafe, as determined by an anaesthesiologist.
- People for whom a safe surgical path to the relevant brain area cannot be identified, or who have known reasons they cannot have brain surgery while lying face down, as determined by a neurosurgeon.
- People who have a known allergy or sensitivity to any ingredient in the study treatment or to contrast agents used in MRI scans (gadolinium-based agents).
- People who are currently using certain forms of levodopa or dopamine-related medication delivered through the skin, under the skin, or by a pump (specifically percutaneous levodopa/carbidopa intestinal gel, subcutaneous levodopa, or an apomorphine pump).
- People who have previously had brain surgery of any kind, including deep brain stimulation (DBS) or focused ultrasound treatment.
- People who are currently on long-term medication that suppresses the immune system.
- People who have previously received any cell therapy or gene therapy.
- People who have taken part in another interventional clinical trial within 12 weeks before screening, or who are unwilling to avoid starting new experimental treatments during this study.
- People whose blood test results at screening fall outside acceptable ranges, including: low platelet counts; abnormal blood clotting times or INR; low neutrophil (a type of white blood cell) count; low haemoglobin (anaemia); elevated liver enzymes; elevated bilirubin (a liver marker); reduced kidney function; or a blood sugar control marker (HbA1c) of 8% or higher.
- People who are unable or unwilling to follow the study procedures, including attending frequent and lengthy follow-up visits as part of the long-term follow-up study (ASK-PD0-CS002).
- People who are unwilling to delay any vaccinations from the screening period through to one month after surgery.
- People identified by the neurologist, neurosurgeon, or anaesthesiologist as having any significant concern that may make participation in the study unsafe or unsuitable.
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.
If you need support right now
This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.
If you or someone else is in immediate danger, call 000.
- Lifeline — 24/7 crisis support: 13 11 14
- Suicide Call Back Service — 24/7 counselling: 1300 659 467
- 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
- Beyond Blue — 24/7 mental health support: 1300 22 4636
- Emergency: 000
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.
Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
GP referral letter
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Trial details
Where this trial is recruiting
Primary endpoints
Amount of the putamen covered by the drug at the end of infusion, assessed by MRI
Can't join this trial?
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.