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Sponsored by: |
Sangamo Biosciences |
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Information provided by: | Sangamo Biosciences |
ClinicalTrials.gov Identifier: | NCT00110500 |
The purpose of this study is to evaluate the clinical and laboratory safety of SB-509 when given as a single treatment by an intramuscular injection to subjects with diabetic neuropathy.
Condition | Intervention | Phase |
---|---|---|
Diabetic Neuropathy |
Genetic: hVEGF-A |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Single Blind, Active Control, Single Group Assignment, Safety Study |
Official Title: | A Phase I Dose-Escalation Clinical Trial of SB-509-0401 in Subjects With Diabetic Neuropathy |
Estimated Enrollment: | 12 |
Study Start Date: | April 2005 |
Study Completion Date: | January 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Primary objective:
To evaluate the clinical and laboratory safety of SB-509 when given as a single treatment by an intramuscular injection. To determine the maximum tolerated dose (MTD) of a single treatment by intramuscular injection by SB-509.
Secondary objective:
To evaluate the lower extremity clinical effects of SB-509 treatment on lower limb diabetic neuropathy by symptoms, neurological examination, and lower extremity electrophysiological testing.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Subjects with the following are NOT eligible to participate in this study:
Study ID Numbers: | SB-509-0401 |
Study First Received: | May 9, 2005 |
Last Updated: | October 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00110500 |
Health Authority: | United States: Food and Drug Administration |
Diabetes Neuropathy |
Neuromuscular Diseases Diabetic Neuropathies Peripheral Nervous System Diseases Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Diabetes Complications |
Nervous System Diseases |