Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00414453
Status:
TERMINATED
Last Update Posted:
2015-07-17
First Post:
2006-12-19
Brief Title:
Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis TALENT-MS
Status:
TERMINATED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Did not reach enrollment goals
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine whether treatment with an extended-release opioid or topical lidocaine is effective in relieving distal symmetric lower extremity burning pain associated with multiple sclerosis MS If treatment with topical lidocaine is efficacious it will have important implications for understanding this chronic pain syndrome which is widely assumed to be caused by central nervous system pathology
Detailed Description:
This study is a single-center double-blind 15-week 3-period crossover clinical trial Subjects will complete each of the following 5-week long periods unless they withdraw from the trial 1 placebo pills and topical lidocaine patches 2extended-release oxycodone pills and placebovehicle patches and 3placebo pills and placebo patches Sixty subjects will be randomized to one of 6 treatment sequences It is expected that this trial will take approximately 2 years to complete
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