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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

January 3, 2020

Primary Completion Date

December 31, 2030

Study Completion Date

December 31, 2030

Conditions
Parkinson Disease
Interventions
BIOLOGICAL

LY3884961

Participants will receive a single dose of LY3884961, administered intra-cisterna magna

DRUG

Methylprednisolone

6 IV pulses administered as concomitant medication over 3 months

DRUG

Sirolimus

Back-up treatment if corticosteroid is not well tolerated. Loading dose, followed by maintenance dose, followed by dose tapering; administered as concomitant medication

Trial Locations (14)

10003

COMPLETED

Mount Sinai Beth Israel, 10 Union Square East, Suite 5H, New York

10065

ACTIVE_NOT_RECRUITING

Joan and Sanford I. Weill Department of Medicine, 525 E 68th Street, New York

32806

COMPLETED

PPD, 100 West Gore Street, Suite 202, Orlando

52621

COMPLETED

Sheba Medical Center, Tel Hashomer, Ramat Gan

55905

NOT_YET_RECRUITING

Mayo Clinic, 200 First Street SW, Rochester

60611

ACTIVE_NOT_RECRUITING

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

64239

COMPLETED

Tel Aviv Sourasky Medical Center, 6 Weizmann St., Tel Aviv

85259

NOT_YET_RECRUITING

Mayo Clinic, 13400 E. Shea Boulevard, Scottsdale

91031

COMPLETED

Shaare Zedek Medical Center, 12 Shmuel Biet Street, Jerusalem

91120

COMPLETED

Hadassah Medical Center, Hadassah Ein Kerem, Dept. of Neurology, P.O. Box 12000, Jerusalem

92562

RECRUITING

Esperanza Clinical, 25220 Hancock Avenue, Murrieta

80113-2776

RECRUITING

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

32751-5669

RECRUITING

K2 Medical Research, 101 Southhall Lane, Suite 150, Maitland

19107-6103

RECRUITING

Hospital of the University of Pennsylvania, 330 S. 9th Street, Philadelphia

Sponsors
All Listed Sponsors
collaborator

Eli Lilly and Company

INDUSTRY

lead

Prevail Therapeutics

INDUSTRY

NCT04127578 - Phase 1/2a Clinical Trial of PR001 (LY3884961) in Patients With Parkinson's Disease With at Least One GBA1 Mutation (PROPEL) | Biotech Hunter | Biotech Hunter