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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01873404 | BG00010 (Neublastin) Phase 2 Multiple Dose Adaptive Design in Participants With Painful Lumbar Radiculopathy | PHASE2 | COMPLETED | 183 | — | — | Jun 1, 2013 | Mar 1, 2015 | Sep 10, 2015 | 25 | United States |
| NCT01842126 | Phase 1 Subcutaneous Single and Multiple Ascending Dose Study of BG00010 (Neublastin) | PHASE1 | COMPLETED | 54 | — | — | Apr 1, 2013 | Aug 1, 2014 | Feb 9, 2015 | 1 | Netherlands |
| Arm | Type | Description |
|---|---|---|
| BG00010 | EXPERIMENTAL | Administered as an IV injection at various dose levels 3 times per week for 1 week |
| Placebo | PLACEBO_COMPARATOR | Matched placebo IV injection 3 times per week for 1 week |
| Single Ascending Dose (SAD): BG00010 | EXPERIMENTAL | Up to five cohorts of healthy volunteers will receive a single dose of intravenous (IV) BG00010 followed by a single SC dose of BG00010 2 weeks apart. |
| SAD: Placebo | EXPERIMENTAL | Up to five cohorts of healthy volunteers will receive a single IV dose of placebo followed by a single SC dose of placebo 2 weeks apart. |
| Multiple Ascending Dose (MAD): BG00010 | EXPERIMENTAL | Up to 6 cohorts of participants with painful lumbar radiculopathy will receive 3 SC doses of BG00010. |
| Multiple Ascending Dose (MAD): Placebo | EXPERIMENTAL | Up to 6 cohorts of participants with painful lumbar radiculopathy will receive 3 SC doses of placebo. |
| Name | Type | Description |
|---|---|---|
| BG00010 | DRUG | As specified in the treatment arm |
| Placebo | DRUG | As specified in the treatment arm |
| BG00010 IV | BIOLOGICAL | Ascending Doses intravenous (IV) of BG00010 |
| BG00010 SC | BIOLOGICAL | Ascending Doses subcutaneous (SC) of BG00010 |
| Placebo IV | DRUG | Ascending Doses intravenous (IV) of Placebo |
| Placebo SC | DRUG | Ascending Doses subcutaneous (SC) of placebo |
Key Inclusion Criteria: * Body weight ≤133 kg. * Leg pain radiating, diagnosed as being due to painful lumbar radiculopathy or lumbosacral radiculopathy, the diagnosis of which occurred within ≥6 months and ≤5 years of the time of randomization. * Objective, documented evidence of painful lumbar ra...