Recruiting NCT06285643
A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AAV2-GDNF gene therapy, control surgery.
- Who it may be relevant to
- Registry conditions: Parkinson Disease. Basic parameters: 45 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Germany, Poland, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
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.
Interventions
- Drug AAV2-GDNF gene therapy
Bilateral image-guided infusion of AAV2-GDNF into putamen, single dose - Procedure control surgery
Bilateral partial burr/twist holes without dural penetration
Primary outcome measures
- Change from baseline to Month 18 on PD Motor Diary [Time frame: 18 months]
Eligibility criteria
Inclusion criteria
Age
- Male and female adults 45-75 years of age inclusive, at the time of signing of informed consent Type of Subject and Disease Characteristics
- Diagnosed with Parkinson's disease in the past 4-10 years (inclusive) as defined by the following:
- Presence of bradykinesia PLUS any of the following:
- Rigidity
- Rest tremor
- Postural instability
- Presence of motor fluctuations as measured by the PD Motor Diary
- Stable anti-parkinsonian medication regimen for >/= 4 weeks prior to screening
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 34 centers
- Mayo Clinic — Phoenix
- UCI Alpha Clinic (Neurology) — Irvine
- Loma Linda University (Neurology) — Loma Linda
- Loma Linda University (Surgical) — Loma Linda
- University of California San Francisco (Neurology) — San Francisco
- University of San Francisco (Surgical) — San Francisco
- CenExel Rocky Mountain Clinical Research (Neurology) — Englewood
- Georgetown University (Neurology) — Washington D.C.
- … and 26 more centers
Germany · 5 centers
- Charité - Universitätsmedizin Berlin (Surgical) — Berlin
- Philipps-Universität Marburg (Neurology) — Marburg
- Universitätsklinikum Tübingen (Neurology) — Tübingen
- Universitätsklinikum Tübingen (Surgical) — Tübingen
- Universitätsklinikum Würzburg (Neurology) — Würzburg
Poland · 5 centers
- Copernicus Podmiot Leczniczy, Szpital św. Wojciecha (Neurology) — Gdansk
- Specjalistyczna Praktyka Lekarska Prof. Grzegorz Opala (Neurology) — Katowice
- Mazowiecki Szpital Bródnowski (Neurology) — Warsaw
- Mazowiecki Szpital Bródnowski (Surgical) — Warsaw
- Samodzielny Publiczny Szpital Kliniczny im. Prof. W. Orłowskiego CMKP (Neurology) — Warsaw
United Kingdom · 2 centers
- North Bristol NHS Trust - Southmead Hospital (Neurology) — Bristol
- University Hospital of Wales (Surgical) — Cardiff
Identifiers
NCT: NCT06285643 · ASK-PD5-CS201