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Virus Therapy

Gene Therapy for Parkinson's Disease (REGENERATE-PD Trial)

Phase 2
Recruiting
Research Sponsored by Asklepios Biopharmaceutical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female adults 45-75 years of age inclusive, at the time of signing of informed consent
Rigidity Rest Tremor Postural instability
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months

Summary

"This trial aims to test the safety and effectiveness of AAV2-GDNF treatment in patients with moderate Parkinson's Disease using a randomized, surgically controlled, and double-blinded approach."

Who is the study for?
Adults aged 45-75 with moderate Parkinson's Disease can join this trial. They should have specific scores on the MDS-UPDRS Part III in an OFF state, experience motor fluctuations for over 2.5 hours daily, and respond to levodopa treatment. Those with severe disease stages or unstable medication regimens cannot participate.
What is being tested?
The study is testing AAV2-GDNF gene therapy versus a control surgery to see if it's safe and effective for Parkinson's when delivered to a brain region called the putamen. It’s randomized and double-blinded, meaning neither participants nor researchers know who gets which treatment until after results are collected.
What are the potential side effects?
While not specified here, gene therapies like AAV2-GDNF may cause immune reactions, swelling at injection sites, headaches or nausea. The exact side effects will be monitored closely given that it’s a Phase 2 study focusing on safety.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 45 and 75 years old.
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I experience stiffness, shaking at rest, and balance issues.
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I experience at least 2.5 hours of worsened mobility daily due to Parkinson's.
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My Parkinson's medication has been stable for 4 weeks and I respond well to levodopa.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline to Month 18 on PD Motor Diary
Secondary study objectives
Change from baseline in the MDS-UPDRS part 1 and PDQ-39
Change from baseline in the MDS-UPDRS parts 2 and 3, and the PD Motor Diary
Change in Levodopa equivalent daily dose

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AAV2-GDNFExperimental Treatment1 Intervention
Group II: Control SurgeryPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

BayerIndustry Sponsor
2,277 Previous Clinical Trials
25,541,026 Total Patients Enrolled
2 Trials studying Dementia
23,022 Patients Enrolled for Dementia
Asklepios Biopharmaceutical, Inc.Lead Sponsor
7 Previous Clinical Trials
346 Total Patients Enrolled
~58 spots leftby Nov 2027
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