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 have been diagnosed with clinically established Parkinson's disease, confirmed by a specific brain imaging scan called a DaTscan.
- People who are able and willing to sign and date a consent form before the study begins.
- People who are between 40 and 75 years of age (inclusive).
- Women who could become pregnant must not be pregnant or breastfeeding, confirmed by a blood pregnancy test at the start of the study.
- Women who could become pregnant, and men, must use an accepted form of contraception from the start of the study until it ends — accepted methods include barrier methods (such as condoms, diaphragm, cervical cap, spermicide, or an IUD), surgical sterilisation (such as vasectomy, hysterectomy, or removal of both ovaries), or being postmenopausal (no periods for at least one year, confirmed by medical history or personal report).
- People who have not yet started any Parkinson's disease treatment.
- People whose Parkinson's disease is at an early stage, rated between 1.0 and 2.0 on the Hoehn and Yahr scale (a measure of how advanced the condition is).
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 Parkinson's diagnosis is uncertain, or where another type of movement disorder is suspected, such as Parkinsonism caused by drugs, toxins, infection, vascular disease, injury, or brain tumour, or conditions such as Parkinson-plus syndromes or Huntington's disease.
- People who have a confirmed diagnosis of another neurodegenerative disease in addition to Parkinson's disease.
- People who have had surgery for Parkinson's disease (such as pallidotomy, deep brain stimulation, or fetal tissue transplantation), or any other brain surgery at any time, even for unrelated conditions.
- People who currently have, or have a history of, an acute psychotic disorder, bipolar disorder, major depressive disorder, or other psychiatric, neurological, or behavioural conditions that could affect their ability to take part in the study.
- People who score below 23 on a standard memory and thinking assessment called the Montreal Cognitive Assessment (MoCA).
- People whose blood test results show significant abnormalities, such as unusual blood cell counts, liver enzyme levels more than three times the normal upper limit, or significantly reduced kidney function (confirm with trial site).
- People who have a pre-existing digestive or gastrointestinal condition that could affect how the study medication is absorbed, such as liver or gallbladder disease (including cholangitis or cholestasis), Crohn's disease, or ulcerative colitis.
- Women who are pregnant or planning to become pregnant.
- People who have a significant neurological condition such as Alzheimer's disease, stroke, brain tumour, multiple sclerosis, or a seizure disorder.
- People who have experienced major depression in the past 12 months, have a major mental illness such as schizophrenia, or have had alcohol or substance abuse issues in the past 12 months.
- People who have taken part in another clinical trial and used any experimental treatment within 30 days before the screening visit.
- People who have a known sensitivity, intolerance, or allergy to the study drug, FHL-301.
- People who have had any thoughts of suicide in the past year.
- People who are unwilling to complete the assessments planned as part of the study.
- People for whom an MRI scan of the head is not safe or suitable.
- People whose MRI scan shows certain abnormalities in brain structure, such as signs of severe brain shrinkage, brain tumours, vascular changes, injury, or abnormal blood vessel formations (confirm with trial site).
- People who have other illnesses that the study doctor believes would put them at risk if they took the study drug, FHL-301.
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: (217) 779-7736
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
Primary endpoints
The Unified Parkinson's Disease Rating Scale
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.