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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00328601 | Assessment of Efficacy and Safety of Thioctic Acid in the Oral Treatment of Symptomatic Diabetic Neuropathy (SYDNEY 2) | PHASE3 | COMPLETED | 170 | — | — | Feb 1, 2005 | Jun 1, 2005 | Feb 7, 2022 | 5 | Israel, Russia |
| NCT00977483 | Assessment of Efficacy and Safety of Thioctic Acid in the Oral Treatment of Diabetic Polyneuropathy (Stage 1 or 2) | PHASE3 | COMPLETED | 460 | — | — | May 1, 1998 | Jan 1, 2005 | Feb 7, 2022 | 38 | United States, Croatia +7 |
| Arm | Type | Description |
|---|---|---|
| Drug: Thioctic Acid | EXPERIMENTAL | 600mg tablet Thioctic Acid (alpha-lipoic acid) once daily throughout the trial |
| Drug: Placebo | PLACEBO_COMPARATOR | 1 tablet once daily throughout the trial |
| Name | Type | Description |
|---|---|---|
| Thioctic Acid | DRUG | - |
| Placebo | DRUG | 1 tablet once daily 4 years double-blind treatment period |
Inclusion Criteria: 1. Diabetes mellitus (Type I or II), as defined by the American Diabetes Association, 1997, lasting 1 year. 2. Patient must have a symmetric sensory-motor peripheral polyneuropathy of at least stage 2 attributable to diabetes mellitus following a thorough evaluation for other ca...