Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00235469
Status:
COMPLETED
Last Update Posted:
2014-09-22
First Post:
2005-10-06
Brief Title:
A Trial to Assess the Efficacy and Safety of SPM 927 in Subjects With Painful Distal Diabetic Neuropathy
Sponsor:
UCB Pharma
Organization:
UCB Pharma
Study Overview
Official Title:
A Multi-center Randomized Double-blind Placebo-controlled Parallel-group Trial to Assess the Efficacy and Safety OF 200 400 AND 600 mgDay SPM 927 in Subjects With Painful Distal Diabetic Neuropathy
Status:
COMPLETED
Status Verified Date:
2010-02
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 phase 2b trial is being conducted at approximately 60 sites in the US to investigate whether lacosamide SPM 927 at different doses reduces pain in subjects with diabetic neuropathy Approximately 360 subjects will be randomized to placebo or one of three doses of lacosamide To qualify for this trial subjects with symptoms of painful distal diabetic neuropathy ranging in duration from 6 months to 5 years must have an average pain intensity of 4 on an 11-point Likert scale 0-10 scale during the 7 day period prior to start of treatment
To determine what effect lacosamide has on diabetic neuropathic pain subjects will use a diary to record their daily pain intensity morning and evening pain interference with sleep morning and activity evening Use of rescue medication acetaminophen and subjects quality of life will be investigated In addition safety and tolerability of the different doses of lacosamide will be investigated
To determine what effect lacosamide has on diabetic neuropathic pain subjects will use a diary to record their daily pain intensity morning and evening pain interference with sleep morning and activity evening Use of rescue medication acetaminophen and subjects quality of life will be investigated In addition safety and tolerability of the different doses of lacosamide will be investigated
Detailed Description:
None
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