Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MDT-15 · 1 trial · 2 indications
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 ...
MDT-15 is an investigational small molecule being developed for the treatment of sciatica, specifically lumbosacral radiculopathy. It is intended for patients with this condition, which involves nerve root compression in the lower back causing pain that radiates down the leg.
MDT-15 is being developed by Medtronic plc, a medical technology company traded on the New York Stock Exchange under the ticker MDT. The company is conducting clinical research on this investigational drug for sciatica.
MDT-15 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy in patients with sciatica.
MDT-15 has one completed Phase 2 clinical trial, identified as NCT01917825, titled 'A Study of the Pharmacokinetics, Safety, and Preliminary Efficacy of MDT-15 in Subjects With Lumbosacral Radiculopathy.' This study enrolled 54 participants in the United States and was not randomized or double-blinded.
No alternative names for MDT-15 have been reported. The drug is identified solely by its code name MDT-15 in clinical trial records and development documentation.