Phase 1/2a Clinical Trial of PR001 (LY3884961) in Patients With Parkinson's Disease With at Least One GBA1 Mutation (PROPEL)
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.
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
- Enrollment
- 32 participants
Conditions and interventions
Conditions
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 2, 2020
- Primary completion
- Mar 30, 2031
- Completion
- Mar 30, 2031
- Last update posted
- Jul 15, 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 Jul 15, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04127578 live on ClinicalTrials.gov.