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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01240876 | Study to Evaluate the Safety and Efficacy of Placulumab (CEP-37247) Administered by the Transforaminal Epidural Route for the Treatment of Patients With Lumbosacral Radicular Pain Associated With Disk Herniation | PHASE1 | COMPLETED | 98 | — | — | Jan 1, 2011 | Apr 1, 2013 | Jul 21, 2016 | 24 | United States, Australia |
The average pain intensity over the past 24 hours on the NRS-11 will be collected daily by electronic diary.
| Arm | Type | Description |
|---|---|---|
| CEP-37247 | EXPERIMENTAL | - |
| Matching placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| CEP-37247 | DRUG | 0.5-, 1-, 3-, 6-, and 12-mg doses of CEP-37247 will be administered by the transforaminal epidural route. |
| Placebo | DRUG | Matching placebo vials will be filled with the buffered solution for CEP-37247. |
Inclusion Criteria: * Over the 4 days prior to the randomization visit, the patient has a mean score greater than or equal to 5 (of 10) for "Average Pain Over the Past 24 Hours" for the pain in the affected leg as assessed by the 11-Point Numerical Rating Scale (NRS-11) captured in the electronic d...