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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01917825 | A Study of the Pharmacokinetics, Safety, and Preliminary Efficacy of MDT-15 in Subjects With Lumbosacral Radiculopathy | PHASE2 | COMPLETED | 54 | — | — | Jul 1, 2013 | Oct 1, 2016 | Apr 20, 2017 | 6 | United States |
The Pharmacokinetics profile (Cmax, Tmax, AUC0-t, and AUC0-∞) following administration of up to six MDT-15 pellets in escalating sequential doses to different cohorts will be evaluated.
The Pharmacokinetics profile (Cmax, Tmax, AUC0-t, and AUC0-∞) following administration of up to six MDT-15 pellets in escalating sequential doses to different cohorts will be evaluated.
The Pharmacokinetics profile (Cmax, Tmax, AUC0-t, and AUC0-∞) following administration of up to six MDT-15 pellets in escalating sequential doses to different cohorts will be evaluated.
The Pharmacokinetics profile (Cmax, Tmax, AUC0-t, and AUC0-∞) following administration of up to six MDT-15 pellets in escalating sequential doses to different cohorts will be evaluated.
Incidence of Adverse Events as a Measure of Safety.
| Arm | Type | Description |
|---|---|---|
| MDT-15 | EXPERIMENTAL | The treatments will be administered to separate, sequential cohorts of 18 treated subjects in the following escalating doses:1 pellet, 3 pellets, and 6 pellets. |
| Name | Type | Description |
|---|---|---|
| MDT-15 | DRUG | - |
Inclusion Criteria: 1. Be male or female at least 18 years of age. 2. Have radiating pain toward the buttock down to the leg and/or feet, unilateral. 3. Have radiologic pathology change from L1 - S1 consistent with a disc protrusion, non-sequestered extrusion, or sequestered fragment, as evidenced ...