MedTrace Logo

AADC Gene Therapy for Parkinson's Disease

NCT02418598 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2019-08-09

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, efficacy of intra-putaminal infusion of AAV-hAADC-2 (adeno-associated virus encoding human aromatic L-amino acid decarboxylase) by stereotaxic surgery in patients with advanced Parkinson's disease.

Conditions

  • Parkinson Disease

Interventions

GENETIC

Cohort1

AAV-hAADC-2 is administered via bilateral intra-putaminal infusion. The number of vector genomes (vg) administered in this cohort is 3x10\^11 vg/subject.

GENETIC

Cohort2

AAV-hAADC-2 is administered via bilateral intra-putaminal infusion. The number of vector genomes (vg) administered in this cohort is 9x10\^11 vg/subject.

Sponsors & Collaborators

  • Takara Bio Inc.

    collaborator INDUSTRY

  • Gene Therapy Research Institution,Co.,Ltd.

    collaborator UNKNOWN

  • Jichi Medical University

    lead OTHER

Principal Investigators

  • Shin-ichi Muramatsu, MD, PhD · Division of Oriental Medicine, Center for Community Medicine, Jichi Medical University; Division of Genetic Therapeutics, Center for Molecular Medicine, Jichi Medical University; Division of Neurology, Department of Medicine, Jichi Medical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-14
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • Japan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02418598 on ClinicalTrials.gov