Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00220337
Status:
COMPLETED
Last Update Posted:
2023-07-24
First Post:
2005-09-01
Brief Title:
A Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy
Sponsor:
UCB Pharma
Organization:
UCB Pharma
Study Overview
Official Title:
A Multicenter Open-label Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy
Status:
COMPLETED
Status Verified Date:
2022-08
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 study is to determine if lacosamide SPM 927 is safe if taken for a longer period of time and whether it continues to work well to treat pain
Subjects will receive lacosamide at a dose that will be individually determined to be the one that provides most pain relief with the least side effects The maximum dose will be 600mgday Subjects may participate in this trial until October 2007 This time may be extended to allow them to participate until lacosamide is commercially available
If a subject meet the requirements for the study at Visit 1 and after a two weeks phase without trial medication she enters a Titration Phase to determine the personal optimal dose of lacosamide When this dose is reached she will enter the Maintenance Phase and will be asked to return for visits every 4 weeks for the first 24 weeks and every 12 weeks thereafter
Subjects will receive lacosamide at a dose that will be individually determined to be the one that provides most pain relief with the least side effects The maximum dose will be 600mgday Subjects may participate in this trial until October 2007 This time may be extended to allow them to participate until lacosamide is commercially available
If a subject meet the requirements for the study at Visit 1 and after a two weeks phase without trial medication she enters a Titration Phase to determine the personal optimal dose of lacosamide When this dose is reached she will enter the Maintenance Phase and will be asked to return for visits every 4 weeks for the first 24 weeks and every 12 weeks thereafter
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 |
|---|---|---|---|
| 2004-000960-28 | EUDRACT_NUMBER | None | None |