Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06438471
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-24
Brief Title:
Novel Soluble Epoxide Hydrolase Inhibitor for Neuropathic Pain in Patients With Spinal Cord Injury
Sponsor:
EicOsis Human Health Inc
Organization:
EicOsis Human Health Inc
Study Overview
Official Title:
Development of a Novel Soluble Epoxide Hydrolase Inhibitor as a Strategy for Treating Neuropathic Pain in Patients With SCI
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to evaluate safety and tolerability of multiple oral doses of EC5026 in male and female patients with neuropathic pain due to spinal cord injury The main question it aims to answer is whether EC5026 is safe and well tolerated in SCI patients with neuropathic pain In addition this trial will also study the effects of EC5026 on pain
Researchers will compare EC5026 to placebo
Participants will be asked to
Take EC5026 or placebo in a masked fashion once daily for 14 consecutive days
Undergo physical exams vital signs assessments ECGs and blood draws
Complete assessments of pain sleep functional status and perception of change
Researchers will compare EC5026 to placebo
Participants will be asked to
Take EC5026 or placebo in a masked fashion once daily for 14 consecutive days
Undergo physical exams vital signs assessments ECGs and blood draws
Complete assessments of pain sleep functional status and perception of change
Detailed Description:
EC5026 has been shown to be effective in preclinical pain models of pain including inflammatory and neuropathic pain subtypes Three Phase 1 studies of EC5026 have been conducted in healthy volunteers a Phase 1a Single Ascending Dose SAD study a Phase 1a Fed-Fasted study and a Phase 1b Multiple Ascending Dose MAD study The Phase 1b MAD study evaluated the safety tolerability and PK of 2 sequential ascending dose regimens of oral EC5026 administered once daily for 7 consecutive days in healthy volunteers The present study will evaluate the safety and tolerability as well as target engagement and pharmacodynamics of EC5026 administered as multiple doses in subjects with neuropathic pain due to spinal cord injury
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