RECRUITING

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

Talk to us

Conditions

Parkinson DiseaseGene therapy

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-06-11
Study Completion:2027-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06285643

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.

Ages Eligible for Study:45 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Diagnosed with Parkinson's Disease in the past 4-10 years (inclusive) as defined by the following:
  3. 1. Presence of bradykinesia PLUS any of the following:
  4. * Rigidity
  5. * Rest Tremor
  6. * Postural instability
  7. 2. Presence of motor fluctuations as measured by the PD Motor Diary
  8. 3. Stable anti-parkinsonian medication regiment for \>/= 4 weeks prior to screening
  9. 4. Must demonstrate responsiveness to levodopa therapy
  1. * Known history or current evidence of medical, genetic, or neurological conditions that may provide an alternative to idiopathic PD diagnosis
  2. * Presence or history of significant vascular and/or cardiovascular disease
  3. * Presence of significant cognitive impairment, poorly controlled depression/anxiety
  4. * Presence or history of psychosis or impulse control disorder
  5. * History of malignancy other than treated cutaneous squamous or basal cell carcinomas
  6. * Presence of clinically relevant conditions that could compromise surgical suitability and/or subject safety
  7. * Contraindication to magnetic resonance imaging and/or use gadolinium-based contrast agents
  8. * Prior history of brain surgery including, but no limited: DBS, pallidotomy focused ultrasound thalamotomy, or other experimental neurosurgical procedure
  9. * Chronic immunosuppressive therapy

Contacts and Locations

Study Contact

Nisha Chhabria, MD
CONTACT
919-388-1040
askfirst@askbio.com
Christian Urrea, MD
CONTACT
919-388-1040
askfirst@askbio.com

Study Locations (Sites)

Loma Linda University (Neurology)
Loma Linda, California, 92354
United States
University of California San Francisco (Neurology)
San Francisco, California, 94143
United States
Parkinson's Disease and Movement Disorders Center of Boca Raton (Neurology)
Boca Raton, Florida, 33486
United States
Parkinson's Disease Treatment Center of Southwest Florida (Neurology)
Port Charlotte, Florida, 33980
United States
University of Kansas Medical Center (Neurology)
Kansas City, Kansas, 66103
United States
Massachusetts General Hospital (Neurology)
Boston, Massachusetts, 02114
United States
Massachusetts General Hospital (Surgical)
Boston, Massachusetts, 02114
United States
Michigan State University (Neurology)
East Lansing, Michigan, 48824
United States
Quest Research Institute (Neurology)
Farmington Hills, Michigan, 48334
United States
Cleveland Clinic Lou Ruvo (Neurology)
Las Vegas, Nevada, 89106
United States
University of North Carolina (Neurology)
Chapel Hill, North Carolina, 27514
United States
Duke University (Neurology)
Durham, North Carolina, 27710
United States
Ohio State University (Surgical)
Columbus, Ohio, 43210
United States
University of Pennsylvania (Neurology)
Philadelphia, Pennsylvania, 19104
United States
Vanderbilt University (Neurology)
Nashville, Tennessee, 37232
United States
Houston Methodist (Neurology)
Houston, Texas, 77030
United States
Houston Methodist (Surgical)
Houston, Texas, 77030
United States
University of Wisconsin (Neurology)
Madison, Wisconsin, 53705
United States

Collaborators and Investigators

Sponsor: Asklepios Biopharmaceutical, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-11
Study Completion Date2027-11-30

Study Record Updates

Study Start Date2024-06-11
Study Completion Date2027-11-30

Terms related to this study

Keywords Provided by Researchers

  • Gene therapy

Additional Relevant MeSH Terms

  • Parkinson Disease