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
Qualifiers
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
Treatments tested in this trial
- AAV2-GDNF gene therapy
- control surgery
Treatment groups
127 Participants
are divided into 2 treatment groupsSponsors and collaborators
AskBio Inc
Lead sponsor
Bayer
Collaborator
Source ClinicalTrials.gov