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 fully understand the study procedures, are willing to take part voluntarily, and have signed the consent form.
- People who are aged 18 or older and under 75 years old at the time of signing the consent form — any gender may apply.
- People who have had a confirmed diagnosis of primary Parkinson's disease for at least 5 years, with documented medical records meeting the International Parkinson and Movement Disorder Society (MDS) diagnostic criteria.
- People whose Parkinson's disease severity, measured during a period when medication has worn off, falls within a specific range (Hoehn-Yahr stage 2 to 4) according to a standard rating scale called the MDS-UPDRS (confirm with trial site).
- People whose movement symptoms, scored during a medication "off" period using part three of the MDS-UPDRS rating scale, score above 30 (confirm with trial site).
- People whose Parkinson's disease condition and medication dose have both been stable for at least 4 weeks before screening, and who have been taking levodopa (a common Parkinson's medication) for at least 1 year.
- People whose symptoms respond positively to levodopa treatment, confirmed by a specific levodopa challenge test conducted during screening.
- People who have noticed that their Parkinson's medication is becoming less effective over time, in a way that affects their day-to-day life.
- People who are able to follow the trial schedule and complete all required assessments.
- People of reproductive potential, and their partners, who have no plans for pregnancy from at least 2 weeks before screening until at least 1 year after receiving the study drug, and who agree to use effective non-hormonal contraception throughout the trial (such as condoms or non-hormonal intrauterine devices) — this does not apply to those who have already had a permanent procedure such as tubal ligation or vasectomy.
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 are allergic to the study drug, its ingredients, or similar types of drugs, or who have a history of severe allergies to any food or medication.
- People who have a previous history of mental disorders, serious illnesses, or other significant health conditions that could affect their safety in the trial.
- People who have a known HIV infection, HIV-related illness, or a positive HIV blood test result.
- People who test positive for hepatitis B surface antigen, hepatitis C antibody, or syphilis (Treponema pallidum) antibody.
- People who have previously been diagnosed with a secondary or atypical form of Parkinson's syndrome caused by medications, a metabolic condition, or another underlying cause.
- People who have previously been diagnosed with epilepsy, stroke, multiple sclerosis, or a neurological condition that is poorly controlled or getting worse over time.
- People who have experienced new or unstable mental health symptoms within the year before screening, such as confusion, severe depression, or thoughts of self-harm or suicide.
- People who have a history of dementia or severe memory and thinking problems, or who show signs of these at screening — including a specific screening score above a set threshold — or whose ability to follow the trial, keep a diary, or sign the consent form is affected by dementia (confirm specific score threshold with trial site).
- People who have other serious conditions affecting major body systems at the time of screening.
- People who have any history of cancer (malignant tumour) at any time in the past.
- People who are currently in another clinical trial, or who took part in a clinical study involving an active treatment within the 3 months before receiving the study drug.
- People who have an active infection at screening that still requires treatment with antibiotics, antifungal, or antiviral medicines at the time the baseline assessment is done.
- People who have had a stroke, unstable chest pain (angina), or a heart attack within the 6 months before screening.
- People who have a history of schizophrenia or other severe mental health conditions, or a history of drug or alcohol misuse.
- Women who are pregnant or breastfeeding.
- People whom the trial investigator considers unsuitable for participation after an overall assessment.
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
Primary endpoints
Incidence of Treatment-Emergent Adverse Events (TEAEs); Severity of Adverse Events; Safety Assessments: Vital Signs; Safety Assessments: Laboratory Parameters; Safety Assessments: Physical Examination
Can't join this trial?
Data last synced from ClinicalTrials.gov: 7 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.