Long Term Follow-Up Study for rAAV-GAD Treated Subjects | NCT01301573

Studies
Long Term Follow-Up Study for rAAV-GAD Treated Subjects

NCT01301573

Sponsor

Neurologix, Inc.

Status

Terminated

Last Update Posted

Feb 22, 2012Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Parkinson's Disease

Interventions

rAAV-GAD

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to financial reasons

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Feb 18, 2011

First Submission Date that Met QC Criteria

Feb 18, 2011

First Posted Date

Feb 23, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2012

Last Update Posted Date

Feb 22, 2012Estimated

Description Module

Brief Summary

The purpose of this observational study is the long term follow-up of Parkinson's patients who participated in a clinical trial in which they received AAV-GAD gene transfer into the subthalamic nucleus (STN) region of the brain. Patients will be followed once a year for up to five (5) years. The study will monitor and evaluate the long term effects of AAV-GAD and provide long term safety information.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
rAAV-GAD Treated Subjects		rAAV-GAD treated subjects who are being observed for long-term effects of the gene therapy product which they received from participating in a previous clinical study.	Biological: rAAV-GAD

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rAAV-GAD	Biological		rAAV-GAD Treated Subjects

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participated in a clinical trial where they received AAV-GAD
Able to give informed consent to participate in the study

Exclusion Criteria:

Received Deep Brain Stimulation after receiving AAV-GAD
Received any experimental device in the brain after receiving AAV-GAD
Had any type of brain surgery after receiving AAV-GAD
Received any experimental therapy (drug or biologic) for Parkinson's disease or any other indication after receiving AAV-GAD

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Parkinson's disease patients who participated in a clinical trial in which they received AAV-GAD gene transfer.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University		Stanford	California	94305-5401	United States
University of Colorado

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided