Phase 1 Parkinson's Disease Trial, Recruiting NCT06565195 Sponsor: Prevail Therapeutics Condition: Parkinson's Disease
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Phase 1 Parkinson's Disease Trial, Recruiting

NCT06565195
Recruiting Phase 1

Who may 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 might be able to join this trial:

  • You are generally in good health, as confirmed by a medical assessment (re-screening is allowed if needed).
  • You score 24 or higher on a standard memory and thinking test called the Montreal Cognitive Assessment.
  • Any regular medications you take have been at a stable dose for at least 8 weeks before the study drug is given, and your doctor expects this to stay the same for at least 6 months.

For the multiple-dose part of the trial only:

  • You have been diagnosed with Parkinson's disease using a specific set of recognised medical guidelines.
  • Your Parkinson's disease is at a relatively early to mid stage (Stage 1 to 2.5 on a standard scale, measured when medication is not active).
  • A specialised spinal fluid test for a Parkinson's-related protein has come back positive — a recent positive result from within the last year may also be accepted with approval (US and Japan only).
  • Your sense of smell scores at or below the 20th percentile for your age and sex on a standard smell test (EU and UK only).
  • A specific brain scan has shown results consistent with Parkinson's disease.
  • If you are not currently taking Parkinson's disease medication, your doctor does not expect you to need to start within 6 months.
  • Your body weight is between 40 kg (88 lbs) and 110 kg (242 lbs), and your body mass index (BMI) is between 17 and 34.

Who may not be able to join:

  • You have a significant neurological condition affecting the brain or nervous system other than Parkinson's disease (multiple-dose part only).
  • You have a current serious or unstable illness affecting the heart, liver, kidneys, digestive system, lungs, hormones, nervous system, mental health, immune system, or blood that could affect your safety or the study results.
  • You are generally frail, or have a condition that could make study procedures unsafe — for example, a serious spinal problem, a bleeding disorder, low platelet counts, or raised pressure in the skull.
  • You have an abnormal heart tracing (ECG) at the screening stage that your doctor believes could increase risks or affect test results.
  • You are currently receiving Parkinson's disease medication delivered continuously through the intestine (for example, a treatment called Duodopa) (multiple-dose part only).
  • Your kidneys are not working well enough, based on a specific blood test result (multiple-dose part only) (confirm with trial site).

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 23 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Travis Lewis, Prevail Therapeutics, a Wholly Owned Subsidiary of Eli Lilly and Company

Phone: 917-336-9310

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
Recruiting
Phase
Phase 1
Sponsor
Prevail Therapeutics
Registry
ClinicalTrials.gov
Start date
27 August 2024
Est. completion
5 May 2029

Where this trial is recruiting

🇯🇵 Japan 🇺🇸 United States

Primary endpoints

Incidence of Serious Adverse Events (SAEs); Incidence of Treatment Emergent Adverse Events (TEAEs); Number of discontinuations due to Adverse Events (AEs)

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: 23 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