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 aged between 30 and 79 years old (inclusive) who have been diagnosed with Parkinson's disease within the last 2 years, using a standard diagnostic checklist called the UK Brain Bank Criteria.
- People whose Parkinson's disease is at an early stage (rated as Stage I or II on a standard scale called Hoehn and Yahr) at the time of screening.
- People who are either newly diagnosed and not currently taking any Parkinson's disease medication, or people who have been on a stable dose of Amantadine or anticholinergic medications for at least 4 weeks before screening. People who stopped other Parkinson's medications (such as levodopa or dopamine agonists) at least 60 days before screening — for example, due to side effects — may also meet this criterion (confirm with trial site).
- People who do not have any significant abnormalities in their physical examination, neurological examination, or standard lab and heart tests, and whose liver enzyme levels (AST, ALT, and ALP) are no more than twice the upper limit of the normal range.
- People who are able to understand the study, provide their own consent, are willing to sign a consent form before screening, and agree to follow the study requirements.
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 form of parkinsonism or parkinsonism caused by something other than Parkinson's disease itself (for example, caused by medications, infections, stroke, or other neurological conditions).
- People who have previously had brain surgery for Parkinson's disease.
- People who, at the time of screening, meet the clinical criteria for bipolar disorder, major depressive disorder, psychotic disorders, or other mental health conditions that the study doctor believes could interfere with the trial.
- People who have been diagnosed with dementia, or who score below 24 on a standard memory and thinking test called the Mini-Mental State Examination (MMSE).
- People who are pregnant or breastfeeding at the time of the trial.
- People who start taking any Parkinson's disease medications (such as levodopa, dopamine agonists, entacapone, or MAO-B inhibitors) during the trial.
- People who start taking Amantadine or anticholinergics during the trial (if newly diagnosed), or who change the dose of these medications during the trial (if already taking them at a stable dose before screening).
- People who have used marijuana or any product containing THC within 3 months before screening, or who plan to use them during the trial.
- People who have taken part in another clinical trial involving an experimental drug or device within 60 days before screening, or an experimental biological treatment within 6 months before screening.
- People who have a significant ongoing medical or surgical condition, or who have had major surgery within 28 days before enrolling in the trial.
- People who have a known allergy or sensitivity to any ingredient in the study treatment.
- People with a history of drinking more than 21 units of alcohol per week (where one unit equals 240 mL of beer, 120 mL of wine, or one shot of spirits), a history of drug misuse in the 6 months before taking the study drug, or a history of substance misuse considered significant by the study doctor.
- Women of childbearing age who are sexually active but are unwilling to use an approved form of contraception throughout the study. Approved methods include abstinence, hormonal contraception (pill, implant, or injection) used together with a barrier method, an intrauterine device (IUD), or being surgically sterile or at least 2 years past menopause. Male participants whose partners could become pregnant must also agree to use a condom consistently throughout the study and for 30 days after the last dose. Participants must also agree not to donate eggs or sperm during the study and for 30 days after the last dose.
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.
Contact this trial
Phone: (301) 956-2531
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.
Primary endpoints
Incidence of Treatment-Emergent Adverse Events (TEAEs); Incidence of withdrawals due to Adverse Events (AEs); Incidence of serious adverse events (SAEs); Columbia-Suicide Severity Rating Scale (C-SSRS); Change of blood pressure (both systolic and diastolic blood pressures); Change of body temperature; Change of respiratory rate; ECG ventricular rate (beats per minute); ECG PR interval (msec); ECG QRS interval (msec); ECG QT interval (msec); ECG QTc interval (msec)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.