A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)
ConditionParkinson Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age45-75
SponsorAskBio Inc
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female adults 45-75 years of age inclusive, at the time of signing of informed consent Type of Subject and Disease Characteristics
Rigidity
Rest tremor
Postural instability
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
AAV2-GDNF gene therapy
DrugBilateral image-guided infusion of AAV2-GDNF into putamen, single dose
control surgery
Procedure/SurgeryBilateral partial burr/twist holes without dural penetration
Treatment groups
127 Participants
are divided into 2 treatment groupsGroup A: AAV2-GDNFExperimental treatment 1 intervention
Group B: Control SurgerySham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline to Month 18 on PD Motor Diary
Normalized Good ON time per Hauser Diary
Time frame
18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
AskBio Inc
Lead sponsor
Bayer
Collaborator
Source ClinicalTrials.gov