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NCT04127578 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Parkinson Disease, sponsored by Prevail Therapeutics.

Active
Registry status
Phase 1
Development phase
32
Enrollment target
15
Study locations

NCT04127578 is a Phase 1 study of Parkinson Disease that is active but no longer recruiting, run by Prevail Therapeutics. The registered enrollment target is 32 participants, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (99% lower). The trial reports 15 study locations across 10 states.

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The verdict

NCT04127578, a Phase 1 study of Parkinson Disease, is active but no longer recruiting, sponsored by Prevail Therapeutics.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
32 participants
Enrollment target
15
Study locations

Study Summary

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.

Conditions Studied

Parkinson Disease

Interventions

  • DRUG Sirolimus
  • DRUG Methylprednisolone
  • BIOLOGICAL LY3884961

Study Locations (15)

Other

  • Shaare Zedek Medical Center, 12 Shmuel Biet Street - Jerusalem
  • Hadassah Medical Center, Hadassah Ein Kerem, Dept. of Neurology, P.O. Box 12000 - Jerusalem
  • Sheba Medical Center, Tel Hashomer - Ramat Gan
  • Tel Aviv Sourasky Medical Center, 6 Weizmann St. - Tel Aviv

Florida

  • K2 Medical Research, 101 Southhall Lane, Suite 150 - Maitland
  • PPD, 100 West Gore Street, Suite 202 - Orlando

New York

  • Mount Sinai Beth Israel, 10 Union Square East, Suite 5H - New York
  • Joan and Sanford I. Weill Department of Medicine, 525 E 68th Street - New York

Arizona

  • Mayo Clinic, 13400 E. Shea Boulevard - Scottsdale

California

  • Esperanza Clinical, 25220 Hancock Avenue - Murrieta

Colorado

  • Rocky Mountain Clinical Research - CenExel - PPDS, 701 East Hampden Avenue Suite 510 - Englewood

Illinois

  • Northwestern University Feinberg School of Medicine, Dept. of Neurology, Parkinson's Disease & Movement Disorders Center, 710 N. Lake Shore Drive, 11th Floor - Chicago

Minnesota

  • Mayo Clinic, 200 First Street SW - Rochester

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2020-01-03
Est. Completion 2030-12-31
Phase Phase 1

Sponsor

Prevail Therapeutics

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04127578

The ClinicalTrials.gov registry entry for NCT04127578 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (99% lower). The listed sponsor is Prevail Therapeutics, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Parkinson Disease appearing as the primary indexed condition, and to 3 interventions - of which Sirolimus is the first listed.

NCT04127578 reports 15 study locations spanning 10 distinct geographic areas - top geographies include Other, Florida, New York.

Frequently Asked Questions

What is clinical trial NCT04127578 about?

NCT04127578 is a clinical study titled "Phase 1/2a Clinical Trial of PR001 (LY3884961) in Patients With Parkinson's Disease With at Least One GBA1 Mutation (PROPEL)". 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 LY3884...

What is the current status of trial NCT04127578?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2020-01-03. Estimated completion is 2030-12-31.

What conditions does trial NCT04127578 study?

This clinical trial studies the following conditions: Parkinson Disease.

What interventions are being tested in trial NCT04127578?

The interventions under investigation include: Sirolimus (DRUG), Methylprednisolone (DRUG), LY3884961 (BIOLOGICAL).

Who is sponsoring clinical trial NCT04127578?

This trial is sponsored by Prevail Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04127578 being conducted?

This trial has 15 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.