A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)

Part of paid clinical trials in Irvine, California.

Sponsor
AskBio Inc
Study ID
NCT06285643
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • AAV2-GDNF gene therapy — DRUG
    Bilateral image-guided infusion of AAV2-GDNF into putamen, single dose
  • control surgery — PROCEDURE
    Bilateral partial burr/twist holes without dural penetration

Study Details

The objective of this randomized, surgically controlled, double-blinded, Phase 2 study is to evaluate the safety and efficacy of AAV2-GDNF delivered to the putamen in subjects with moderate Parkinson's Disease.

Key Dates

Start date
Jun 11, 2024
Status verified
Apr 2025
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
127 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AAV2-GDNF
  • Sham Comparator: Control Surgery

Primary Outcome Measure

Change from baseline to Month 18 on PD Motor Diary [ Time Frame: 18 months ]

Central Contacts

Locations (27)

FacilityCityStateZIPSite coordinators
UCI Alpha Clinic (Neurology)IrvineCalifornia92697
[email protected]
949-824-3990
Loma Linda University (Neurology)Loma LindaCalifornia92354
Julie Lacanlale
[email protected]
Loma Linda University (Surgical)Loma LindaCalifornia92354-
University of California San Francisco (Neurology)San FranciscoCalifornia94143
University of San Francisco (Surgical)San FranciscoCalifornia94143-
CenExel Rocky Mountain Clinical Research (Neurology)EnglewoodColorado80113
720-776-0092
Georgetown University (Neurology)Washington D.C.District of Columbia20057
Luke Lovelace
[email protected]
Parkinson's Disease and Movement Disorders Center of Boca Raton (Neurology)Boca RatonFlorida33486
Lauren Salmon
[email protected]
561-392-1818
Parkinson's Disease Treatment Center of Southwest Florida (Neurology)Port CharlotteFlorida33980-
Emory University (Surgical)AtlantaGeorgia30322-
Rush University Medical Center (Neurology)ChicagoIllinois60612
Neepa J. Patel, MD
312-563-2900
University of Kansas Medical Center (Neurology)Kansas CityKansas66103
Massachusetts General Hospital (Neurology)BostonMassachusetts02114
Massachusetts General Hospital (Surgical)BostonMassachusetts02114-
Michigan State University (Neurology)East LansingMichigan48824
Leigh Whittet
[email protected],
517-884-2275
Quest Research Institute (Neurology)Farmington HillsMichigan48334
Denise Morgott
[email protected]
Cleveland Clinic Lou Ruvo (Neurology)Las VegasNevada89106
Liliana Dumitrescu
[email protected]
702-483-6016
University of North Carolina (Neurology)Chapel HillNorth Carolina27514
Hans Nettesheim
[email protected]
Duke Neurosurgery (Surgical)DurhamNorth Carolina27705-
Duke University (Neurology)DurhamNorth Carolina27710
Karen White-Tong
[email protected]
919-668-2905
Ohio State University (Surgical)ColumbusOhio43210-
University of Pennsylvania (Neurology)PhiladelphiaPennsylvania19104
Neda Almassi
[email protected]
215-829-7289
Vanderbilt University (Neurology)NashvilleTennessee37232
Haley Kling
[email protected]
615-208-3974
Houston Methodist (Neurology)HoustonTexas77030
Daniel Arnaud Dominguez
[email protected]
Houston Methodist (Surgical)HoustonTexas77030-
EvergreenHealth Research Department (Neurology)KirklandWashington98034
Gowri Rajendran
[email protected]
University of Wisconsin (Neurology)MadisonWisconsin53705

Find similar trials in Irvine, CA

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
UCI Alpha Clinic (Neurology)· Irvine, CALoma Linda University (Neurology)· Loma Linda, CALoma Linda University (Surgical)· Loma Linda, CAUniversity of California San Francisco (Neurology)· San Francisco, CAUniversity of San Francisco (Surgical)· San Francisco, CACenExel Rocky Mountain Clinical Research (Neurology)· Englewood, CO

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