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Clinical Trial Details

Trial ID: L4094
Source ID: NCT00406458
Associated Drug: Sb-509
Title: Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 1|Diabetes Mellitus, Type 2|Diabetic Polyneuropathy
Interventions: DRUG: SB-509|OTHER: Normal Saline
Outcome Measures: Primary: 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: Safety, One year
Sponsor/Collaborators: Sponsor: Sangamo Therapeutics | Collaborators: Juvenile Diabetes Research Foundation
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 110
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2006-11
Completion Date: 2009-05
Results First Posted:
Last Update Posted: 2012-11-01
Locations: 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
URL: https://clinicaltrials.gov/show/NCT00406458