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Active, not recruiting Phase 1Phase 2 Interventional

Phase 1/2a Clinical Trial of PR001 (LY3884961) in Patients With Parkinson's Disease With at Least One GBA1 Mutation (PROPEL)

ClinicalTrials.gov ID: NCT04127578

Public ClinicalTrials.gov record NCT04127578. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 5:29 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1/2a Open-Label Ascending Dose Study to Evaluate the Safety and Effects of LY3884961 in Patients With Parkinson's Disease With at Least One GBA1 Mutation (PROPEL)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Study J3Z-MC-OJAA is a Phase 1/2a, multicenter, open-label, ascending dose, first in-human study that will evaluate the safety of intracisternal LY3884961 administration in patients with moderate to severe Parkinson's disease with at least 1 pathogenic GBA1 mutation. Two dose level cohorts of LY3884961 are planned (Dose Level 1 and Dose Level 2). The duration of the study is 5 years. During the first year, patients will be evaluated for the effect of LY3884961 on safety, tolerability, immunogenicity, biomarkers, and clinical efficacy measures. Patients will continue to be followed for an additional 4 years to continue to monitor safety as well as selected biomarker and efficacy measures.

Study identification

NCT ID
NCT04127578
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Prevail Therapeutics
Industry
Enrollment
32 participants

Conditions and interventions

Interventions

Biological · Drug

Eligibility (public fields only)

Age range
35 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 3, 2020 (Actual)
Primary completion
Aug 31, 2031 (Estimated)
Completion
Aug 31, 2031 (Estimated)
Last update posted
Oct 13, 2026

2020 – 2031

United States locations

U.S. sites
11
U.S. states
9
U.S. cities
10
Facility City State ZIP Site status
Mayo Clinic, 13400 E. Shea Boulevard Scottsdale Arizona 85259 —
Esperanza Clinical, 25220 Hancock Avenue Murrieta California 92562 —
Rocky Mountain Clinical Research - CenExel - PPDS, 701 East Hampden Avenue Suite 510 Englewood Colorado 80113-2776 —
K2 Medical Research, 101 Southhall Lane, Suite 150 Maitland Florida 32751-5669 —
PPD, 100 West Gore Street, Suite 202 Orlando Florida 32806 —
Northwestern University Feinberg School of Medicine, Dept. of Neurology, Parkinson's Disease & Movement Disorders Center, 710 N. Lake Shore Drive, 11th Floor Chicago Illinois 60611 —
Mayo Clinic, 200 First Street SW Rochester Minnesota 55905 —
Mount Sinai Beth Israel, 10 Union Square East, Suite 5H New York New York 10003 —
Joan and Sanford I. Weill Department of Medicine, 525 E 68th Street New York New York 10065 —
Hospital of the University of Pennsylvania, 330 S. 9th Street Philadelphia Pennsylvania 19107-6103 —
Vanderbilt University Medical Center, 1500 21st Avenue South Suite 2600 Nashville Tennessee 37212 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04127578, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 13, 2026 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04127578 live on ClinicalTrials.gov.

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