Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy
A Phase 2 Repeat Dosing Clinical Trial of SB-509 in Subjects With Moderate to Severe Diabetic Neuropathy and Unmeasurable Nerve Conduction Velocity
1 other identifier
interventional
91
2 countries
20
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 May 2007
Typical duration for phase_2
20 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
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 18, 2007
CompletedFirst Posted
Study publicly available on registry
May 22, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedNovember 1, 2012
October 1, 2012
3.2 years
May 18, 2007
October 30, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total Neuropathy Score (TNS),Evoked nerve conduction velocity (NCV), Quantitative Sensory Testing (QST), %of subjects with conversion of unmeasurable to measurable NCV and NIS-LL
One year
Secondary Outcomes (1)
Safety
One year
Study Arms (2)
1
EXPERIMENTALSB-509
2
PLACEBO COMPARATORInterventions
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 moderate to severe 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.
- Unmeasurable nerve conduction velocity in any lower extremity nerve: peroneal, tibial or sural due to diabetic polyneuropathy
- 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 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
Study Sites (20)
Coordinated Clinical Research
La Jolla, California, 92037, United States
Advanced Medical Research, LLC
Lakewood, California, 90712, United States
Torrance Clinical Research
Lomita, California, 90707, 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
Neurology Clinical Research
Sunrise, Florida, 33351, United States
Laszlo J. Mate', M.D.
West Palm Beach, Florida, 33407, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Creighton Diabetes Center
Omaha, Nebraska, 68131, United States
Advanced Biomedical Research of America
Las Vegas, Nevada, 89123, 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
Neurological Institute Columbia University College of Physicians and Surgeons
New York, New York, 10032, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Nerve and Muscle Center of Texas
Houston, Texas, 77030, United States
Diabetes Center of the Southwest
Midland, Texas, 79705, United States
DGD Research
San Antonio, Texas, 78229, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
Instituto Mexicano de Investigación Clinica
Mexico City, Col. Roma, 06700, Mexico
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2007
First Posted
May 22, 2007
Study Start
May 1, 2007
Primary Completion
July 1, 2010
Study Completion
December 1, 2010
Last Updated
November 1, 2012
Record last verified: 2012-10