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ACTIVE NOT RECRUITINGPhase2

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

Sponsor: AskBio Inc

NCT ID: NCT06285643

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
AAV2-GDNF gene therapy (drug), control surgery (procedure)
How long the study runs
Study runs about 50 months (dates as stated)
About the drug or intervention
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
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
45 Years to 75 Years
Who
All
Number of participants
127
Started
2024-06-11
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for parkinson disease
  • • Phase2 - 127 participants
  • • 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

Who can take part?

  • • Ages 45 Years to 75 Years
  • • Diagnosed with parkinson disease

Where?

  • • Bristol - North Bristol NHS Trust - Southmead Hospital (Neurology)
  • • Cardiff - University Hospital of Wales (Surgical)

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Parkinson Disease

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 45 Years - 75 Years
  • Who can join: All genders

What the study is looking for

  • ✓Male and female adults 45-75 years of age inclusive, at the time of signing of agreement to take part Type of Subject and...
  • ✓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

Who cannot take part

  • ✗Known history or current evidence of medical, genetic, or neurological conditions that may provide an alternative to...
  • ✗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 cancer other than treated cutaneous squamous or basal cell carcinomas
See the full criteria
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

Where Is This Study? (2 UK sites)

North Bristol NHS Trust - Southmead Hospital (Neurology)

Bristol, United Kingdom

Hospital R&D contact (matched)

Helen Lewis-White

Research@nbt.nhs.uk0117 41 49330

University Hospital of Wales (Surgical)

Cardiff, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-09