drugset / Trial / NCT05480228
EPPIC-Net: Novaremed Painful Diabetic Peripheral Neuropathy ISA
Phase 2
Completed
127 enrolled
Massachusetts General Hospital
Icahn School of Medicine at Mount Sinai · collabNational Institute of Neurological Disorders and Stroke (NINDS) · collabNew York University · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to investigate the safety and efficacy of the current hard gelatin capsule formulation of NRD135S.E1 80 mg once daily in the treatment of PDPN when administered for 13 weeks.
Timeline
- Start
- 2022-09-21
- Primary completion
- 2025-08-31
- Completion
- 2025-08-31
Publications
- Background Dworkin RH, Turk DC, Peirce-Sandner S, McDermott MP, Farrar JT, Hertz S, Katz NP, Raja SN, Rappaport BA. Placebo and treatment group responses in postherpetic neuralgia vs. painful diabetic peripheral neuropathy clinical trials in the REPORT database. Pain. 2010 Jul;150(1):12-16. doi: 10.1016/j.pain.2010.02.002. Epub 2010 Mar 3. No abstract available.
- Background Tarpey T, Petkova E, Ciarleglio A, Ogden RT. Extracting scalar measures from functional data with applications to placebo response. Stat Interface. 2021;14(3):255-265. doi: 10.4310/20-sii633.
- Background Tarpey T, Petkova E, Lu Y, Govindarajulu U. Optimal Partitioning for Linear Mixed Effects Models: Applications to Identifying Placebo Responders. J Am Stat Assoc. 2010 Jan 1;105(491):968-977. doi: 10.1198/jasa.2010.ap08713.
- Background Van Buuren, S., & Groothuis-Oudshoorn, K. (2011). Journal of Statistical Software mice: Multivariate Imputation by Chained Equations in R (Vol. 45). http://www.jstatsoft.org/
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NRD135S.E1 | Small molecule | 80 mg | — |