Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy
A Phase 2 Repeat Dosing Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy
1 other identifier
interventional
110
2 countries
15
Brief Summary
The purpose of the study is to study the clinical effects of the investigational drug, SB-509 versus placebo in patients with diabetic neuropathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2006
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 30, 2006
CompletedFirst Posted
Study publicly available on registry
December 4, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedNovember 1, 2012
October 1, 2012
2.1 years
November 30, 2006
October 30, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual analog scale for pain intensity (VASPI), Nerve Conduction Velocity (NCV), Total Neuropathy Score (TNS), Epidermal Nerve Fiber Density (ENFD) & Epidermal Nerve Fiber Density Regeneration (ENFDR)
One year
Secondary Outcomes (1)
Safety
One year
Study Arms (2)
SB-509
EXPERIMENTAL60 mg SB-509 injected IM into lower limbs every 2 months
Normal Saline
PLACEBO COMPARATORNormal saline injected IM into lower limbs every 2 months
Interventions
Eligibility Criteria
You may qualify if:
- Have a clinical diagnosis of diabetes mellitus type I or II for at least 12 months prior to the study.
- Have received a diagnosis of mild to moderate sensorimotor diabetic neuropathy from a neurologist (a doctor who specializes in disorders of the nervous system) or endocrinologist (a doctor who specializes in diabetes). This type of neuropathy is a loss of sensation and muscle function that occurs in the legs and hands in a stocking and glove distribution. Subjects with diabetic neuropathy that results in loss of sensation or muscle function in only one nerve and results in loss of nerve function of the blood vessels and causes low blood pressure, will not be eligible.
- If female and of childbearing potential, agree to use a medically acceptable physical barrier method during the study.
- Have blood pressure \< 140/90 mm Hg
- Body mass index (BMI) \< 38 kg/m2
You may not qualify if:
- Subjects with the following are NOT eligible to participate in this study:
- Have moderate to severe ischemic heart disease, any history of congestive heart failure, or have had a myocardial infarction (heart attack) within the previous 6 months.
- Have chronic foot or leg ulcers for \>1 month, gangrene in the legs, or any previous amputation of the lower extremity.
- Have symptoms of intermittent claudication (or leg pain during exercise associated with peripheral artery disease) and/or an ankle brachial index (or a calculation of the difference between arm and leg blood pressures) of less than (\<) 0.75.
- Have a history of cancer within the past 5 years (except for curable non-melanoma cancer of the skin, superficial bladder cancer in complete remission, or any other cancer that has been in complete remission for at least 5 years).
- Have colon polyps. If patients have a history of benign colonic polyps that have been removed, they must have evidence of a normal colonoscopy within the last 12 months.
- Require any drug that depresses patients' immune systems (such as methotrexate, cyclophosphamide, or cyclosporine) when they receive the study drug and for 30 days afterwards.
- Have a known disorder that affects patients' immune systems (such as HIV/AIDS, hepatitis B virus \[HBV\], hepatitis C virus \[HCV\], sarcoidosis, tuberculosis, rheumatoid arthritis, or autoimmune disorders).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sangamo Therapeuticslead
- Juvenile Diabetes Research Foundationcollaborator
Study Sites (15)
Coordinated Clinical Research
La Jolla, California, 92037, United States
Advanced Medical Research, LLC
Lakewood, California, 90712, United States
SF Clinical Research Center
San Francisco, California, 94109, United States
Diablo Clinical Research
Walnut Creek, California, 94598, United States
Bradenton Research Center
Bradenton, Florida, 34205, United States
University of Miami, Diabetes Research Institute
Miami, Florida, 33136, United States
Neurology Clinical Research
Sunrise, Florida, 33351, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Creighton Diabetes Center
Omaha, Nebraska, 68131, United States
Upstate Clinical Research
Albany, New York, 12205, United States
Peripheral Neuropathy Center, Weill Medical College of Cornell University
New York, New York, 10022, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Nerve and Muscle Center of Texas
Houston, Texas, 77030, United States
DGD Research
San Antonio, Texas, 78229, United States
Instituto Mexicano de Investigación Clinica
Mexico City, Col. Roma, 06700, Mexico
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2006
First Posted
December 4, 2006
Study Start
November 1, 2006
Primary Completion
December 1, 2008
Study Completion
May 1, 2009
Last Updated
November 1, 2012
Record last verified: 2012-10