Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01079325 | Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy | PHASE2 | COMPLETED | 170 | — | — | Nov 1, 2009 | Apr 1, 2016 | May 23, 2022 | 31 | United States |
| NCT00665145 | Stem Cell Mobilization in Diabetic Neuropathy Subjects Receiving SB-509 | PHASE2 | COMPLETED | 23 | — | — | Jan 1, 2008 | Oct 1, 2009 | Nov 1, 2012 | 4 | United States |
| NCT00476931 | Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy | PHASE2 | COMPLETED | 91 | — | — | May 1, 2007 | Dec 1, 2010 | Nov 1, 2012 | 20 | United States, Mexico |
| NCT00406458 | Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy | PHASE2 | COMPLETED | 110 | — | — | Nov 1, 2006 | May 1, 2009 | Nov 1, 2012 | 15 | United States, Mexico |
| Arm | Type | Description |
|---|---|---|
| SB-509 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | Saline |
| 1 | EXPERIMENTAL | Cohort 1 |
| 2 | EXPERIMENTAL | Cohort 2 |
| 3 | PLACEBO_COMPARATOR | Cohort 3 |
| 4 | EXPERIMENTAL | Cohort 4 |
| Normal Saline | PLACEBO_COMPARATOR | Normal saline injected IM into lower limbs every 2 months |
| Name | Type | Description |
|---|---|---|
| SB-509 | DRUG | SB-509 60 mg, 3 treatments, and 5 months treatment period |
| Saline | OTHER | - |
| Placebo | DRUG | Placebo |
| Normal Saline | OTHER | - |
Key Inclusion Criteria: * Clinical diagnosis of Diabetes Mellitus Type I or II for at least 12 months * Clinical signs and symptoms of moderate to severe diabetic sensory-motor polyneuropathy of the lower extremities for at least 6 months that are not otherwise attributed to an etiology other than ...