Printed from Voxsanity (voxsanity.com.au) — NCT07055087 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Parkinson's Disease Trial, Not Yet Recruiting
NCT07055087
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 Parkinson's disease according to the MDS (Movement Disorder Society) diagnostic criteria.
- People who carry one copy of a severe GBA gene mutation known to be linked to Parkinson's disease (confirmed by genetic testing).
- If recruitment is slow after 6 months, the trial may also consider people who carry a specific GBA gene variant called E326K, which is associated with Parkinson's disease risk — the trial sponsor would announce this in advance.
- People who score 21 or above on the MoCA, a standard short memory and thinking test.
- People whose Parkinson's symptoms, when their medication is working well, are at stage 3 or below on the Hoehn and Yahr scale (a measure of how far Parkinson's has progressed).
- People who are between 35 and 80 years old at the time of signing the consent form.
- People who are willing and able to give written consent and follow the study procedures as required by international and local research guidelines.
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 carry a known gene mutation in any of the following genes linked to inherited Parkinson's disease: PRKN, PINK1, DJ1, or LRRK2.
- People whose medical history suggests a form of parkinsonism other than typical Parkinson's disease, such as progressive supranuclear palsy, multiple system atrophy, drug-induced parkinsonism, essential tremor, or primary dystonia.
- People who have been diagnosed with a significant brain or nervous system condition other than Parkinson's disease.
- People who have previously had, are currently receiving, or are planning to receive (within the next 2 years) deep brain stimulation (DBS) surgery or a brain treatment using focused ultrasound.
- People whose brain MRI scan (taken within the past 2 years) shows certain significant abnormalities, such as a prior bleed or stroke larger than 1 cm³, more than 3 small strokes, or severe white matter damage (confirm with trial site).
- People with an autoimmune disease, though some well-controlled conditions such as inactive rheumatoid arthritis, controlled type 1 diabetes, or mild-to-moderate psoriasis not needing systemic medication may be considered after discussion with the trial sponsor.
- People with a history of cancer in the past 5 years, with some exceptions such as certain treated skin cancers, early-stage cervical changes, non-spreading prostate cancer, or Stage I uterine cancer.
- People who have an active infection at the time of the screening visit.
- People who have had a problem with alcohol or drug misuse or dependence (not including nicotine) within the past 12 months; marijuana use in any form — including for therapeutic purposes — is not permitted.
- People who have had a fever or febrile illness within one week before the first dose of the study drug.
- People who have a current psychiatric diagnosis (such as severe depression, schizophrenia, bipolar disorder, or intellectual disability) that may affect their ability to take part and complete study assessments — note that mild depression, low mood, or mild anxiety related to Parkinson's disease are not exclusionary.
- People showing active suicidal thoughts with any intention to act, as measured by a specific standardised scale (C-SSRS) at screening or at the start of the study.
- People who have had a heart attack in the 12 months before the start of the study.
- People with a documented history of an uncontrolled abnormally slow heart rate on more than one occasion in the 3 months before the start of the study.
- People with a resting heart rate above 110 beats per minute.
- People with a documented history of uncontrolled high blood pressure on more than one occasion in the 3 months before the start of the study.
- People with clinically significant heart disease, including unstable chest pain, severe heart failure, or significant heart rhythm problems.
- People with significantly abnormal liver blood test results at screening (specifically, certain liver enzymes more than twice the upper limit of normal).
- People with significantly abnormal kidney function at screening (specifically, creatinine more than 1.5 times the upper limit of normal).
- People with significantly abnormal blood counts at screening, including low red blood cell levels (below 35% for males or 32% for females), very low white blood cells, low platelets, or an abnormal blood clotting result (confirm with trial site).
- People with a clinically significant abnormal thyroid function test result.
- People who test positive on a urine drug screen for a substance of abuse, with some specific exceptions related to certain medications (confirm with trial site).
- People who test positive for active or chronic hepatitis B, hepatitis C, or HIV — though people who have successfully cleared hepatitis C or who are immune to hepatitis B through prior infection or vaccination may still be eligible.
- Women who are able to become pregnant and are not using a highly effective form of contraception (one with a failure rate of less than 1% per year) during the treatment period and for at least 90 days after the last dose of the study drug.
- Women who are pregnant or breastfeeding; women who could become pregnant must have a negative blood pregnancy test before starting the study drug.
- People currently taking Parkinson's symptom medications — such as dopamine agonists, MAO-B inhibitors, COMT inhibitors, amantadine, or levodopa — who have not been on a stable dose for at least 90 days before the start of the study (note: continuous levodopa pump therapy is acceptable if the dose has been stable for at least 90 days).
- People with active Gaucher's disease who are receiving enzyme replacement therapy (ERT) or substrate reduction therapy (SRT) for that condition.
- People taking anti-epileptic medication for a non-seizure reason whose dose has not been stable for at least 90 days before the start of the study and is not planned to remain stable during the study.
- People taking antidepressant or anti-anxiety medication whose dose has not been stable for at least 90 days before the start of the study and is not planned to remain stable during the study.
- People who have taken certain specific medications within the 90 days before the start of the study, including typical antipsychotics, metoclopramide, flunarizine, and several others listed in the trial criteria (confirm full list with trial site) — note that amantadine, quetiapine, and clozapine are allowed if the dose has been stable for at least 90 days.
- People who have previously taken part in, or are currently enrolled in, a trial testing a surgical or stem cell treatment aimed at modifying Parkinson's disease.
- People who have taken part in a clinical trial of a symptomatic or disease-modifying Parkinson's treatment within 90 days before the start of the study, or within 5 times the drug's half-life, whichever is longer.
- People who have previously received any experimental Parkinson's vaccine, including treatments using monoclonal antibodies targeting Parkinson's-related proteins.
- People who have previously taken part in any trial involving prasinezumab or any other treatment targeting the alpha-synuclein protein.
- People who have received any non-Parkinson's investigational drug or device within 90 days before the start of the study, or within 5 times the drug's half-life, whichever is longer.
- People who have received a monoclonal antibody or experimental immune-modifying treatment within 180 days before the start of the study, or within 5 times the drug's half-life, whichever is longer.
- People who have taken immune-modifying drugs, including oral corticosteroids, within 90 days before the start of the study.
- People who have a known allergy to any ingredient in prasinezumab (including citrate, trehalose, or polysorbate 20), or who have had a significant allergic or infusion reaction to any other monoclonal antibody treatment.
- People for whom a brain MRI scan cannot be performed due to contraindications (such as severe claustrophobia or certain dental implants).
- People who have donated more than 500 mL of blood within 3 months before the screening visit.
- For the optional spinal fluid (cerebrospinal fluid) sample collection by lumbar puncture: people with certain specific conditions that make a lumbar puncture unsafe — such as a blood clotting problem, low platelet count, infection at the needle site, use of blood-thinning medication (with some exceptions), severe spinal arthritis, or certain other spinal or brain conditions — would not be able to provide this optional sample, though they may still be able to participate in the rest of the trial.
- People who are under legal guardianship or supervision.
- People who are not fluent in the language used in the country where the trial is being conducted.
- People who live in a nursing home or assisted care facility.
- People who are currently enrolled in any other interventional clinical 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.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
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
Principal Investigator: Kathrin Brockmann, Prof. Dr., University Hospital Tuebingen
Phone: +49 7071 29 80438
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
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
University Hospital Tuebingen
Registry
ClinicalTrials.gov
Start date
1 December 2025
Est. completion
1 December 2030
Where this trial is recruiting
🇫🇷 France
🇩🇪 Germany
🇮🇹 Italy
🇱🇺 Luxembourg
🇪🇸 Spain
🇸🇪 Sweden
🇬🇧 United Kingdom
Primary endpoints
Parkinson's Disease Cognitive Composite Score (PDCCS)
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.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.