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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AAV2-GDNF | Experimental |
| |
| Control Surgery | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AAV2-GDNF gene therapy | Drug | Bilateral image-guided infusion of AAV2-GDNF into putamen, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Month 18 on PD Motor Diary | Normalized Good ON time per Hauser Diary | 18 months |
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Inclusion Criteria:
Age
Male and female adults 45-75 years of age inclusive, at the time of signing of informed consent Type of Subject and Disease Characteristics
Diagnosed with Parkinson's disease in the past 4-10 years (inclusive) as defined by the following:
Presence of bradykinesia PLUS any of the following:
Presence of motor fluctuations as measured by the PD Motor Diary
Stable anti-parkinsonian medication regimen for >/= 4 weeks prior to screening
Must demonstrate responsiveness to levodopa therapy
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nisha Chhabria, MD | Contact | 919-388-1040 | askfirst@askbio.com | |
| Gayathri Palety, MD | Contact | 919-388-1040 | askfirst@askbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Not yet recruiting | Phoenix | Arizona | 85054 | United States |
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| Label | URL |
|---|---|
| Nurse Navigator Service for Potential Participants | View source |
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| control surgery | Procedure | Bilateral partial burr/twist holes without dural penetration |
|
| UCI Alpha Clinic (Neurology) | Recruiting | Irvine | California | 92697 | United States |
|
| Loma Linda University (Neurology) | Recruiting | Loma Linda | California | 92354 | United States |
|
| Loma Linda University (Surgical) | Active, not recruiting | Loma Linda | California | 92354 | United States |
| University of California San Francisco (Neurology) | Recruiting | San Francisco | California | 94143 | United States |
|
| University of San Francisco (Surgical) | Active, not recruiting | San Francisco | California | 94143 | United States |
| CenExel Rocky Mountain Clinical Research (Neurology) | Recruiting | Englewood | Colorado | 80113 | United States |
|
| Georgetown University (Neurology) | Recruiting | Washington D.C. | District of Columbia | 20057 | United States |
|
| Parkinson's Disease and Movement Disorders Center of Boca Raton (Neurology) | Recruiting | Boca Raton | Florida | 33486 | United States |
|
| University of Florida | Not yet recruiting | Gainesville | Florida | 32608 | United States |
|
| University of Miami | Not yet recruiting | Miami | Florida | 33125 | United States |
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| Orlando Health Neuroscience Institute | Recruiting | Orlando | Florida | 32806 | United States |
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| Parkinson's Disease Treatment Center of Southwest Florida (Neurology) | Recruiting | Port Charlotte | Florida | 33980 | United States |
|
| Emory University (Surgical) | Active, not recruiting | Atlanta | Georgia | 30322 | United States |
| Rush University Medical Center (Neurology) | Recruiting | Chicago | Illinois | 60612 | United States |
|
| University of Kansas Medical Center (Neurology) | Recruiting | Kansas City | Kansas | 66103 | United States |
|
| Massachusetts General Hospital (Neurology) | Recruiting | Boston | Massachusetts | 02114 | United States |
|
| Massachusetts General Hospital (Surgical) | Active, not recruiting | Boston | Massachusetts | 02114 | United States |
| Michigan State University (Neurology) | Recruiting | East Lansing | Michigan | 48824 | United States |
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| Quest Research Institute (Neurology) | Recruiting | Farmington Hills | Michigan | 48334 | United States |
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| Cleveland Clinic Lou Ruvo (Neurology) | Recruiting | Las Vegas | Nevada | 89106 | United States |
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| Columbia University | Recruiting | New York | New York | 10032 | United States |
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| University of North Carolina (Neurology) | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
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| Duke Neurosurgery (Surgical) | Active, not recruiting | Durham | North Carolina | 27705 | United States |
| Duke University (Neurology) | Recruiting | Durham | North Carolina | 27710 | United States |
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| Ohio State University (Surgical) | Active, not recruiting | Columbus | Ohio | 43210 | United States |
| University of Pennsylvania (Neurology) | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Vanderbilt University (Neurology) | Recruiting | Nashville | Tennessee | 37232 | United States |
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| Texas Movement Disorder Specialists | Not yet recruiting | Georgetown | Texas | 78628 | United States |
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| Houston Methodist (Neurology) | Recruiting | Houston | Texas | 77030 | United States |
|
| Houston Methodist (Surgical) | Active, not recruiting | Houston | Texas | 77030 | United States |
| University of Utah | Not yet recruiting | Salt Lake City | Utah | 84132 | United States |
|
| EvergreenHealth Research Department (Neurology) | Recruiting | Kirkland | Washington | 98034 | United States |
|
| University of Wisconsin (Neurology) | Recruiting | Madison | Wisconsin | 53705 | United States |
|
| Charité - Universitätsmedizin Berlin (Surgical) | Active, not recruiting | Berlin | Germany |
| Philipps-Universität Marburg (Neurology) | Recruiting | Marburg | Germany |
|
| Universitätsklinikum Tübingen (Neurology) | Recruiting | Tübingen | Germany |
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| Universitätsklinikum Tübingen (Surgical) | Active, not recruiting | Tübingen | Germany |
| Universitätsklinikum Würzburg (Neurology) | Recruiting | Würzburg | Germany |
|
| Copernicus Podmiot Leczniczy, Szpital św. Wojciecha (Neurology) | Recruiting | Gdansk | Poland |
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| Specjalistyczna Praktyka Lekarska Prof. Grzegorz Opala (Neurology) | Recruiting | Katowice | Poland |
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| Mazowiecki Szpital Bródnowski (Neurology) | Recruiting | Warsaw | Poland |
|
| Mazowiecki Szpital Bródnowski (Surgical) | Active, not recruiting | Warsaw | Poland |
| Samodzielny Publiczny Szpital Kliniczny im. Prof. W. Orłowskiego CMKP (Neurology) | Recruiting | Warsaw | Poland |
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| North Bristol NHS Trust - Southmead Hospital (Neurology) | Recruiting | Bristol | United Kingdom |
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| University Hospital of Wales (Surgical) | Active, not recruiting | Cardiff | United Kingdom |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| D001688 | Biological Products |
| ID | Term |
|---|---|
| D045424 | Complex Mixtures |
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