Ignite Creation Date:
2024-05-06 @ 5:56 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05480228
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2022-07-25
Brief Title:
EPPIC-Net Novaremed Painful Diabetic Peripheral Neuropathy ISA
Sponsor:
James P Rathmell MD
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
EPPIC-Net EN21-01 a Multicenter Randomized Double-Blind Placebo-Controlled Study to Assess the Safety and Efficacy of 80 Mg Daily of NRD135SE1 Versus Placebo in Adult and Elderly Participants with Painful Diabetic Peripheral Neuropathy
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EN21-01
Brief Summary:
The purpose of this study is to investigate the safety and efficacy of the current hard gelatin capsule formulation of NRD135SE1 80 mg once daily in the treatment of PDPN when administered for 13 weeks
Detailed Description:
This ISA describes a double-blind Phase II study of the PKPD safety tolerability and effect of 13 weeks of NRD135SE1 80mgday as an ISA within the context of the Platform Protocol to Assess Treatments for Painful Diabetic Peripheral Neuropathy EN21-PP The ISA is intended to be read and interpreted within the context of the Platform Protocol and focuses on the description of design features that are specific to NRD135SE1
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OT2NS122680-01 | NIH | None | httpsreporternihgovquickSearchOT2NS122680-01 |