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

Description

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.

Conditions

Parkinson Disease

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Study Overview

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Study Details

Study overview

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.

A Phase 2, Randomized, Double-blind, Sham Surgery-controlled Study of the Efficacy and Safety of Intraputaminal AAV2-GDNF in the Treatment of Adults With Moderate Stage Parkinson's Disease

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

Condition
Parkinson Disease
Intervention / Treatment

-

Contacts and Locations

Loma Linda

Loma Linda University (Neurology), Loma Linda, California, United States, 92354

San Francisco

University of California San Francisco (Neurology), San Francisco, California, United States, 94143

Boca Raton

Parkinson's Disease and Movement Disorders Center of Boca Raton (Neurology), Boca Raton, Florida, United States, 33486

Port Charlotte

Parkinson's Disease Treatment Center of Southwest Florida (Neurology), Port Charlotte, Florida, United States, 33980

Kansas City

University of Kansas Medical Center (Neurology), Kansas City, Kansas, United States, 66103

Boston

Massachusetts General Hospital (Neurology), Boston, Massachusetts, United States, 02114

Boston

Massachusetts General Hospital (Surgical), Boston, Massachusetts, United States, 02114

East Lansing

Michigan State University (Neurology), East Lansing, Michigan, United States, 48824

Farmington Hills

Quest Research Institute (Neurology), Farmington Hills, Michigan, United States, 48334

Las Vegas

Cleveland Clinic Lou Ruvo (Neurology), Las Vegas, Nevada, United States, 89106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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 regiment for \>/= 4 weeks prior to screening
  • 4. Must demonstrate responsiveness to levodopa therapy
  • * 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

Ages Eligible for Study

45 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Asklepios Biopharmaceutical, Inc.,

Study Record Dates

2027-11-30