Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00350103
Status:
COMPLETED
Last Update Posted:
2024-03-22
First Post:
2006-07-06
Brief Title:
A Trial to Assess the Efficacy and Safety of 400mgDay Lacosamide in Subjects With Painful Diabetic Neuropathy
Sponsor:
UCB Pharma
Organization:
UCB Pharma
Study Overview
Official Title:
A Multi-center Randomized Double-blind Placebo-controlled Trial to Assess the Efficacy and Safety of 400mgDay Lacosamide in Subjects With Painful Distal Diabetic Neuropathy Using Two Different Titration Schemes
Status:
COMPLETED
Status Verified Date:
2023-09
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:
The purpose of this trial is to assess whether 400mgday of lacosamide is effective in reducing pain caused by distal diabetic neuropathy Two dose-escalation schemes for lacosamide will be used to further determine the efficacy of the standard scheme and to evaluate the efficacy and safety of a more rapid titration scheme Subjects will be randomly assigned to one of three treatment groups Subjects in two of the groups will receive lacosamide at a dose of 400mgday but different dose-escalation schemes will be used to reach this final dose The third group of subjects will receive a placebo Subjects will have a 2 in 3 66 chance of getting lacosamide
The maximum lacosamide dose in this trial will be 400mgday The maximum treatment duration will be 18 weeks including a two-week Pre-Treatment Phase and a 12 weeks period on a stable dose of lacosamide or placebo
The maximum lacosamide dose in this trial will be 400mgday The maximum treatment duration will be 18 weeks including a two-week Pre-Treatment Phase and a 12 weeks period on a stable dose of lacosamide or placebo
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-005788-27 | EUDRACT_NUMBER | None | None |