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Clinical Trials in the UK / NCT06285643
Recruiting Phase 2

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

NCT06285643 · tracked via the Priya Life Science UK tracker
Sponsor
AskBio Inc
Phase
Phase 2
Started
2024-06-11
Last updated
2026-06-29

Condition(s) studied

Parkinson Disease

Investigational drug(s) / intervention(s)

AAV2-GDNF gene therapycontrol surgery

AAV2-GDNF gene therapy: Bilateral image-guided infusion of AAV2-GDNF into putamen, single dose

control surgery: Bilateral partial burr/twist holes without dural penetration

Study summary

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.

Eligibility

Sex
ALL
Min age
45 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: Age 1. Male and female adults 45-75 years of age inclusive, at the time of signing of informed consent Type of Subject and Disease Characteristics 2. Diagnosed with Parkinson's disease in the past 4-10 years (inclusive) as defined by the following: 1. Presence of bradykinesia PLUS any of the following: * Rigidity * Rest tremor * Postural instability 2. Presence of motor fluctuations as measured by the PD Motor Diary 3. Stable anti-parkinsonian medication regimen for \>/= 4 weeks prior to screening 4. Must demonstrate responsiveness to levodopa therapy Exclusion Criteria: * Known history or current evidence of medical, genetic, or neurological conditions that may provide an alternative to idiopathic PD diagnosis * Presence or history of significant vascular and/or cardiovascular disease * Presence of significant cognitive impairment, poorly controlled depression/anxiety * Presence or history of psychosis or impulse control disorder * History of malignancy other than treated cutaneous squamous or basal cell carcinomas * Presence of clinically relevant conditions that could compromise surgical suitability and/or subject safety * Contraindication to magnetic resonance imaging and/or use gadolinium-based contrast agents * Prior history of brain surgery including, but no limited: DBS, pallidotomy focused ultrasound thalamotomy, or other experimental neurosurgical procedure * Chronic immunosuppressive therapy

Primary outcome measure(s)

Trial sites (46)

FacilityCityRegionStatus
Mayo Clinic Phoenix Arizona Not Yet Recruiting
UCI Alpha Clinic (Neurology) Irvine California Recruiting
Loma Linda University (Neurology) Loma Linda California Recruiting
Loma Linda University (Surgical) Loma Linda California Active Not Recruiting
University of California San Francisco (Neurology) San Francisco California Recruiting
University of San Francisco (Surgical) San Francisco California Active Not Recruiting
CenExel Rocky Mountain Clinical Research (Neurology) Englewood Colorado Recruiting
Georgetown University (Neurology) Washington D.C. District of Columbia Recruiting
Parkinson's Disease and Movement Disorders Center of Boca Raton (Neurology) Boca Raton Florida Recruiting
University of Florida Gainesville Florida Not Yet Recruiting
University of Miami Miami Florida Not Yet Recruiting
Orlando Health Neuroscience Institute Orlando Florida Recruiting
Parkinson's Disease Treatment Center of Southwest Florida (Neurology) Port Charlotte Florida Recruiting
Emory University (Surgical) Atlanta Georgia Active Not Recruiting
Rush University Medical Center (Neurology) Chicago Illinois Recruiting
University of Kansas Medical Center (Neurology) Kansas City Kansas Recruiting
Massachusetts General Hospital (Neurology) Boston Massachusetts Recruiting
Massachusetts General Hospital (Surgical) Boston Massachusetts Active Not Recruiting
Michigan State University (Neurology) East Lansing Michigan Recruiting
Quest Research Institute (Neurology) Farmington Hills Michigan Recruiting
Cleveland Clinic Lou Ruvo (Neurology) Las Vegas Nevada Recruiting
Columbia University New York New York Recruiting
University of North Carolina (Neurology) Chapel Hill North Carolina Recruiting
Duke Neurosurgery (Surgical) Durham North Carolina Active Not Recruiting
Duke University (Neurology) Durham North Carolina Recruiting
Ohio State University (Surgical) Columbus Ohio Active Not Recruiting
University of Pennsylvania (Neurology) Philadelphia Pennsylvania Recruiting
Vanderbilt University (Neurology) Nashville Tennessee Recruiting
Texas Movement Disorder Specialists Georgetown Texas Not Yet Recruiting
Houston Methodist (Neurology) Houston Texas Recruiting
Houston Methodist (Surgical) Houston Texas Active Not Recruiting
University of Utah Salt Lake City Utah Not Yet Recruiting
EvergreenHealth Research Department (Neurology) Kirkland Washington Recruiting
University of Wisconsin (Neurology) Madison Wisconsin Recruiting
Charité - Universitätsmedizin Berlin (Surgical) Berlin Germany Active Not Recruiting
Philipps-Universität Marburg (Neurology) Marburg Germany Recruiting
Universitätsklinikum Tübingen (Neurology) Tübingen Germany Recruiting
Universitätsklinikum Tübingen (Surgical) Tübingen Germany Active Not Recruiting
Universitätsklinikum Würzburg (Neurology) Würzburg Germany Recruiting
Copernicus Podmiot Leczniczy, Szpital św. Wojciecha (Neurology) Gdansk Poland Recruiting

+ 6 more sites — see the full list on the official registry below.

More AskBio Inc trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06285643 on ClinicalTrials.gov ↗ ← All trials in the UK