Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy
NCT ID: NCT00406458
Last Updated: 2012-11-01
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
110 participants
INTERVENTIONAL
2006-11-30
2009-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study doctor will test SB-509 (60 mg) and placebo. Everyone in this study will receive intramuscular (IM-directly into the muscle) injections into both legs. This will happen 3 times over about 4 months. Two out of every 3 participants will receive SB-509 and 1 out of every 3 will receive placebo. You will not know, and the study doctor will not know, whether you will receive SB-509 or whether you will receive placebo.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SB-509
60 mg SB-509 injected IM into lower limbs every 2 months
SB-509
60 mg dose
Normal Saline
Normal saline injected IM into lower limbs every 2 months
Normal Saline
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SB-509
60 mg dose
Normal Saline
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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).
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Juvenile Diabetes Research Foundation
OTHER
Sangamo Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Coordinated Clinical Research
La Jolla, California, United States
Advanced Medical Research, LLC
Lakewood, California, United States
SF Clinical Research Center
San Francisco, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
Bradenton Research Center
Bradenton, Florida, United States
University of Miami, Diabetes Research Institute
Miami, Florida, United States
Neurology Clinical Research
Sunrise, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Creighton Diabetes Center
Omaha, Nebraska, United States
Upstate Clinical Research
Albany, New York, United States
Peripheral Neuropathy Center, Weill Medical College of Cornell University
New York, New York, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Nerve and Muscle Center of Texas
Houston, Texas, United States
DGD Research
San Antonio, Texas, United States
Instituto Mexicano de Investigación Clinica
Mexico City, Col. Roma, Mexico
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Sponsor website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SB-509-0601
Identifier Type: -
Identifier Source: org_study_id