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Clinical Trial Details

Trial ID: L2239
Source ID: NCT01079325
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: Saline
Outcome Measures: Primary: To compare the effect of SB-509 versus placebo in subjects with moderately severe diabetic neuropathy (DN) on sural Nerve Conduction Velocity (NCV) at six-months, 6 months | Secondary: To evaluate the effect of SB-509 on Neuropathy Impairment Score - Lower Limb (NIS-LL), motor Nerve Conduction Velocity (NCV), Quantitative Sensory Testing (QST), Intraepidermal Nerve Fiber Density (IENFD), and Lower Extremity Neurological Sensory Exam, 12 months|To evaluate the effect of SB-509 using a multi-endpoint analysis that includes NIS-LL, Sural NCV, and IENFD, 12 months|To evaluate the safety of SB-509 in subjects with moderately severe diabetic neuropathy, 12 months
Sponsor/Collaborators: Sponsor: Sangamo Therapeutics | Collaborators: Juvenile Diabetes Research Foundation
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 170
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2009-11
Completion Date: 2016-04
Results First Posted:
Last Update Posted: 2022-05-23
Locations: 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
URL: https://clinicaltrials.gov/show/NCT01079325

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress