Ignite Creation Date:
2024-05-06 @ 5:54 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05476276
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2022-07-25
Brief Title:
EPPIC-Net Platform Protocol to Assess Treatments for Painful Diabetic Peripheral Neuropathy
Sponsor:
James P Rathmell MD
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
EPPIC-Net Platform Protocol to Assess Treatments for Painful Diabetic Peripheral Neuropathy
Status:
RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
This is a Platform Protocol to perform Phase II clinical trials in The Early Phase Pain Investigation Clinical Network EPPIC-Net under The Helping to End Addiction Long-termSM Initiative or NIH HEAL InitiativeSM related to the treatment of Painful Diabetic Peripheral Neuropathy PDPN in a platform setting to test multiple assets under a single protocol
Detailed Description:
This is a Platform Protocol that allows evaluation of more than one treatment in a single trial structure to be run within EPPIC-Net Instead of testing individual assets in a series of clinical trials this Platform Protocol sets out the framework for testing multiple assets related to PDPN This provides an efficient approach to evaluate multiple therapies under a single infrastructure in a timely fashion The Platform Protocol also allows efficiencies by creating the possibility of sharing information across assets such as data from control conditions
This Platform Protocol is for a platform design to allow for the testing of multiple assets Some platform trials allow direct comparisons of competing therapies for the same condition However for this EPPIC-Net platform trial there will not be direct comparisons of assets to one another Instead assets will only be compared to a placebo This is in service to the EPPIC-Net primary goal of accelerating the development of pain treatment because based on feedback from asset-holders the possibility of comparison of assets to one another or to an active drug would be a deterrent for asset-holders participation in EPPIC-Net
This Platform Protocol is for a platform design to allow for the testing of multiple assets Some platform trials allow direct comparisons of competing therapies for the same condition However for this EPPIC-Net platform trial there will not be direct comparisons of assets to one another Instead assets will only be compared to a placebo This is in service to the EPPIC-Net primary goal of accelerating the development of pain treatment because based on feedback from asset-holders the possibility of comparison of assets to one another or to an active drug would be a deterrent for asset-holders participation in EPPIC-Net
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 |
|---|---|---|---|
| 5U24NS113850-03 | NIH | None | httpsreporternihgovquickSearch5U24NS113850-03 |