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MDT-0123 · 1 trial · 2 indications
Bone fusion status 12 months visit after index procedure The success rate of bone fusion at the 12-month visit after the index procedure will be evaluated. Imaging evaluations will be performed at baseline, after the index procedure (to discharge), at 3, 6, and 12 months (CT scan will be performed at baseline, 6, and 12 months only), and imaging evaluation for the primary efficacy endpoint will be performed by the core laboratory at the 12-month visit. Primary endpoints
Incidence of Adverse Device Effects in both groups up to 12 months post index procedure. To evaluate the rate of subjects experiencing any adverse device effects in both groups that occurring up to 12-month visit after the index procedure.
| Arm | Type | Description |
|---|---|---|
| MDT-0123 | ACTIVE_COMPARATOR | - |
| Iliac bone graft (ICBG) | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| MDT-0123 | COMBINATION_PRODUCT | Use a combination of the MDT-0123 spine cage and the MDT-0123 kit. |
| ICBG | DEVICE | Use a combination of the MDT-0123 spine cage and ICBG |
Inclusion Criteria: * Requirement for bone fusion via consecutive 2-level spinal fusion due to disc degeneration or spinal deformity in the lumbosacral spine (L2-S1) * Symptomatic degenerative lesions from L2 to S1 confirmed by imaging (MRI or myelography within 12 months prior to enrollment) with ...
MDT-0123 is an investigational small molecule being developed for the treatment of disc degeneration, a condition affecting the spinal discs. It is currently in Phase 3 clinical development and is being studied in patients with disc degeneration and spinal deformity.
MDT-0123 is being developed by Medtronic plc, a medical technology company traded on the New York Stock Exchange under the ticker symbol MDT. The drug is currently in Phase 3 clinical trials for disc degeneration.
MDT-0123 is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 trial is currently recruiting participants to evaluate its safety and efficacy in disc degeneration.
MDT-0123 is being studied in a Phase 3 clinical trial with the identifier NCT07414745, titled 'MDT-0123 Japan Study'. This randomized, placebo-controlled trial is recruiting 140 participants in Japan and is investigating the drug for disc degeneration and spinal deformity.
Yes, MDT-0123 is a small molecule drug. It is being developed as a therapeutic for disc degeneration and is currently in Phase 3 clinical trials. The drug is administered as an investigational treatment in a placebo-controlled study.