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AAV-hAADC-2

Phase 1

Parkinson's Disease | Gene therapy | Neurology |Sanofi|Last Updated: Dec 4, 2013

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Clinical trial landscape

AAV-hAADC-2 · 1 trial · 1 indication

Phase 1 1
NCT00229736A Study of AAV-hAADC-2 in Subjects With Parkinson's DiseaseParkinson's Disease
COMPLETED10 Analytics
PHASE1COMPLETED
A Study of AAV-hAADC-2 in Subjects With Parkinson's Disease
Parkinson's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

The safety and tolerability of intrastriatal administration of AAV-hAADC-2 as measured by Adverse Events in subjects with mid- to late-stage Parkinson's Disease.
Time of treatment through Month 60.

Secondary Endpoints

The effect of AAV-hAADC-2 on clinical status as recorded in subject diaries, by clinical assessment, and daily levodopa requirement.
Time of treatment through Month 60.
The relationship between the dose of AAV-hAADC-2 vector infused and the resulting level of striatal AADC expression by FMT-PET imaging.
Time of treatment through Month 60
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AAV-hAADC-2 (9x10^10 vector genomes)EXPERIMENTAL -
AAV-hAADC-2 (3x10^11 vector genomes)EXPERIMENTAL -

Interventions

NameTypeDescription
AAV-hAADC-2GENETIC9 x 10\^10 vector genomes (vg) of AAV-hAADC-2 in a single dose of 200 µL bilaterally infused over 4 striatal targets
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Eligibility Criteria

Age Range40 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Documented informed consent. * Diagnosis of idiopathic Parkinson's disease (two of four cardinal features - tremor, bradykinesia, rigidity and postural instability - plus early dopaminergic responsiveness of symptoms and absence of any cardinal signs of more widespread neurolo...

Countries:United States
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Frequently asked questions about AAV-hAADC-2

What is AAV-hAADC-2 used for in Parkinson's Disease?

AAV-hAADC-2 is an investigational gene therapy being studied for the treatment of Parkinson's Disease. It is designed to deliver a gene that may help produce an enzyme involved in dopamine synthesis, potentially addressing the motor symptoms of the condition. It is currently in clinical development and is not yet approved.

Who makes AAV-hAADC-2?

AAV-hAADC-2 is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. The company is conducting clinical research to evaluate the safety and efficacy of this gene therapy for Parkinson's Disease.

What phase is AAV-hAADC-2 in?

AAV-hAADC-2 is in Phase 1 clinical development. This early-stage trial is designed to assess the safety, tolerability, and preliminary efficacy of the gene therapy in patients with Parkinson's Disease. The study has been completed, but the drug remains investigational and has not received regulatory approval.

What clinical trials is AAV-hAADC-2 in?

AAV-hAADC-2 has been studied in one clinical trial, identified as NCT00229736, titled 'A Study of AAV-hAADC-2 in Subjects With Parkinson's Disease.' This Phase 1 trial enrolled 10 participants in the United States and has been completed. The study included adults aged 40 years and older.

How does AAV-hAADC-2 work?

AAV-hAADC-2 is a gene therapy that uses an adeno-associated virus (AAV) vector to deliver the human aromatic L-amino acid decarboxylase (AADC) gene. This gene encodes an enzyme that converts levodopa to dopamine, potentially enhancing dopamine production in the brain and improving motor function in Parkinson's Disease patients.