drugset / Trial / NCT04469270
Study to Assess Safety and Efficacy of Engensis in Painful Diabetic Peripheral Neuropathy
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of intramuscular administration of Engensis on pain in participants with painful diabetic peripheral neuropathy in the feet and lower legs, as compared to Placebo, as a second Phase 3, well controlled study, sufficient in supporting the efficacy and safety of Engensis.
Timeline
- Start
- 2020-11-20
- Primary completion
- 2023-03-24
- Completion
- 2024-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Engensis | Other / unclassified | 0.25 mg | Intramuscular |
| Subject | Engensis | Other / unclassified | 0.5 ml | Intramuscular |