Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06649747
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-14
Brief Title:
Efficacy Study With AFA-281 for the Treatment of Back Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Double-blind Placebo-controlled Multi-center Phase II Study of the Safety Tolerability Pharmacokinetics and Efficacy of Oral AFA-281 in Patients With Painful Lumbosacral Radiculopathy
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 if the drug candidate AFA-281 works to treat chronic low back and leg pain caused by painful lumbosacral radiculopathy PLSR in adults This trial will also evaluate the safety of AFA-281 The main questions it aims to answer are
Does AFA-281 mitigate pain
What are the side effects if any Researchers will compare AFA-281 to a placebo a look-alike substance that contains no drug to see if AFA-281 works to treat chronic low back and leg pain
Participants will
Take drug AFA-281 or a placebo three times every day for 4 weeks
Visit the clinic once every 2 weeks for checkups and tests
Keep a diary of their pain scores and about mood and sleep questionnaires and the number of times they use a rescue pain medicines
Does AFA-281 mitigate pain
What are the side effects if any Researchers will compare AFA-281 to a placebo a look-alike substance that contains no drug to see if AFA-281 works to treat chronic low back and leg pain
Participants will
Take drug AFA-281 or a placebo three times every day for 4 weeks
Visit the clinic once every 2 weeks for checkups and tests
Keep a diary of their pain scores and about mood and sleep questionnaires and the number of times they use a rescue pain medicines
Detailed Description:
This is a randomized double-blind placebo-controlled multicenter Phase II study of the efficacy safety tolerability and PK of oral AFA-281 in 300 patients with painful lumbosacral radiculopathy PLSR Patients will be randomized in to the placebo group or doses of AFA-281 titrated over 2 weeks to reach planned daily doses for Weeks 3 and 4 Trials will be conducted simultaneously at 3 sites to meet enrollment targets The primary efficacy endpoint is 24-hour average pain score based on the 0-10-point Numeric Pain Rating Scale NPRS and key secondary endpoint is Oswestry Disability Index ODI rates of adverse events and PK among others
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None