Parkinson's DiseaseNCT01301573
Long Term Follow-Up Study for rAAV-GAD Treated Subjects
An observational study of Parkinson's Disease, run by Neurologix, Inc. at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- rAAV-GAD
- How many people
- 40 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2011to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parkinson's disease patients who participated in a clinical trial in which they received AAV-GAD gene transfer.
Who may be able to join
- Participated in a clinical trial where they received AAV-GAD
- Able to give informed consent to participate in the study
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Colorado
Aurora, Colorado, 80045
Massachusetts General Hospital
Boston, Massachusetts, 0211
The Ohio State University
Columbus, Ohio, 43210
Henry Ford Health Systems
Southfield, Michigan, 48034
Stanford University
Stanford, California, 94305-5401
Wake Forest University Health Science Center
Winston-Salem, North Carolina, 27157
About this study
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.
- Conditions
- Parkinson's Disease
- Being tested
- rAAV-GAD
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rAAV-GADBiological
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: rAAV-GAD |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startJan 2011
Why it stopped: Due to financial reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurologix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301573
- Sponsor's protocol ID
- GAD-LTFU
- Status last verified
- Feb 2012
- First submitted
- 18 Feb 2011
- Last updated
- 22 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow-Up Study for rAAV-GAD Treated Subjects
- ClinicalTrials.gov ID
- NCT01301573
- Acronym / sponsor ID
- GAD-LTFU
- Conditions
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to financial reasons
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Neurologix, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- First posted
- 23 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rAAV-GAD Treated Subjects | – | Biological: rAAV-GADrAAV-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. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson's disease patients who participated in a clinical trial in which they received AAV-GAD gene transfer.
Key inclusion criteria (2 listed)
- Participated in a clinical trial where they received AAV-GAD
- Able to give informed consent to participate in the study
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rAAV-GAD | Biological | rAAV-GAD Treated Subjects |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Due to financial reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Neurologix, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to financial reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2012.