Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy
NCT ID: NCT01079325
Last Updated: 2022-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
170 participants
INTERVENTIONAL
2009-11-30
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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SB-509
SB-509
SB-509 60 mg, 3 treatments, and 5 months treatment period
Placebo
Saline
Saline
Interventions
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SB-509
SB-509 60 mg, 3 treatments, and 5 months treatment period
Saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical signs and symptoms of moderate to severe diabetic sensory-motor polyneuropathy of the lower extremities for at least 6 months that are not otherwise attributed to an etiology other than diabetes
* Measurable sural and peroneal response bilaterally
* HgbA1C level ≤ 10%
* LDL cholesterol ≤ 160 mg/dL
* Blood pressure ≤ 140/90 mm Hg
* Body mass index (BMI) ≤ 38
Exclusion Criteria
* Evidence of cardiac enlargement and/or congestive heart failure
* Current diabetic foot or leg ulcer, gangrene in the lower extremity, or any amputation of the lower extremity
* History of malignancy, except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, adequately treated Stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for at least 5 years
* Immune or immunodeficiency disorders or expected to require immunosuppressants for 30 days prior to, during, and for 30 days following administration of the investigational drug product
* History of or current proliferative retinopathy, macular edema or retinal neovascularization
* Pre-cancerous conditions or benign tumors which have the potential for clinically significant growth due to VEGF stimulation
* Family history of inherited neuropathy (e.g. Charcot Marie Tooth, Hereditary Predisposition to Pressure Palsy)
18 Years
80 Years
ALL
No
Sponsors
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Juvenile Diabetes Research Foundation
OTHER
Sangamo Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Winson Tang, MD
Role: STUDY_DIRECTOR
Sangamo BioSciences, Inc
Locations
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Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Chino, California, United States
Fresno, California, United States
La Jolla, California, United States
Los Angeles, California, United States
National City, California, United States
San Francisco, California, United States
Walnut Creek, California, United States
Boulder, Colorado, United States
DeLand, Florida, United States
Fort Myers, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Idaho Falls, Idaho, United States
Meridian, Idaho, United States
Lexington, Kentucky, United States
Boston, Massachusetts, United States
Kansas City, Missouri, United States
Las Vegas, Nevada, United States
Winston-Salem, North Carolina, United States
Tulsa, Oklahoma, United States
Greer, South Carolina, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Countries
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Related Links
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Related Info
Other Identifiers
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SB-509-0901
Identifier Type: -
Identifier Source: org_study_id
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