Phase 2 Parkinson's Disease Trial, Not Yet Recruiting NCT07280299 Sponsor: Gain Therapeutics, Inc. Condition: Parkinson's Disease
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Phase 2 Parkinson's Disease Trial, Not Yet Recruiting

NCT07280299
Not Yet Recruiting Phase 2

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 willing and able to give written consent and follow the study's requirements and restrictions
  • People who are willing to undergo genetic testing and analysis related to Parkinson's disease (PD)
  • People of any sex, aged between 30 and 85 years old
  • People with a body mass index (BMI) between 18 and 40, and a body weight between 55 kg and under 120 kg at the screening visit
  • People who have been diagnosed with Parkinson's disease according to a specific set of medical guidelines called the MDS criteria
  • People who are within 5 years of their Parkinson's disease diagnosis
  • People who test positive for a specific biological marker in their spinal fluid (called a seed amplification assay, or SAA) at the start of the study (confirm with trial site)
  • People whose Parkinson's disease symptoms fall within a certain range of severity, rated 1 to 2.5 on a scale called the Hoehn & Yahr scale (confirm with trial site)
  • People who have either never taken medication for Parkinson's disease and are not expected to start dopaminergic treatment in the first 9 months of the study, or who have been on a stable Parkinson's medication dose for at least 3 months before screening (including at least 4 weeks at the same dose), with no changes to medication expected in the first 9 months
  • People who are not currently pregnant or breastfeeding
  • People who are able to become pregnant or who produce viable sperm must agree to use two forms of contraception (including a barrier method and a second highly effective method) if engaging in sexual activity that could result in pregnancy
  • People who agree not to participate in any other investigational (clinical trial) study during this study

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 other neurological conditions, including (but not limited to) Alzheimer's disease, ALS, frontotemporal dementia, progressive supranuclear palsy, corticobasal syndrome, Huntington's disease, multiple system atrophy, dementia with Lewy bodies, medication-induced parkinsonism, multiple sclerosis, or epilepsy
  • People whose Parkinson's disease is linked to a specific gene variant called LRRK2, or other PD-related genetic mutations other than GBA1
  • People with severe movement complications or disabling involuntary movements, as assessed by the investigating doctor
  • People who have had deep-brain stimulation
  • People experiencing hallucinations, delusions, or other psychotic symptoms that require antipsychotic medication, or who are currently taking dopamine-blocking (antipsychotic) or anticholinergic medications
  • People who have been clinically diagnosed with dementia, or who score 20 or below on a cognitive assessment called the MoCA, or who have a history of behavioural impairment
  • People who have a known allergy or sensitivity to the study drug GT‑02287 or any of its ingredients
  • People taking certain other medications at the same time, including drugs processed mainly through a liver enzyme called CYP3A4 with a narrow safe dosing range, certain other medications with a narrow safe dosing range, or strong/moderate inhibitors or strong inducers of CYP3A4 — this includes some herbal supplements and certain foods (confirm with trial site)
  • People with certain other medical conditions including, but not limited to, serious heart or cardiovascular conditions, diabetes, autoimmune disease, cancer, active infections, psychotic disorders, depressive symptoms, or drug and/or alcohol misuse as defined in the study protocol
  • People with clinically significant abnormal results on laboratory tests
  • People for whom a lumbar puncture (spinal tap) is not safe or appropriate, including those currently taking blood-thinning medications
  • People who have donated more than 500 mL of blood within the 3 months before screening
  • People with a condition affecting how the body absorbs food or medication that could affect absorption of the study drug GT‑02287
  • People who have taken part in another interventional clinical study within 3 months, or within 5 half-lives of the previous study drug (whichever is longer), before the screening visit

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.
Last synced 29 July 2026

Contact this trial

Principal Investigator: Jonas Hannestad, CMO, Gain Therapeutics, Inc.

Phone: +41919211131

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
Gain Therapeutics, Inc.
Registry
ClinicalTrials.gov
Start date
30 May 2026
Est. completion
30 June 2028

Primary endpoints

Change from Baseline to Week 48 in the sum of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II score and Part III score [Efficacy]

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 29 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.

View original record on ClinicalTrials.gov