| August 27, 2007 |
| November 11, 2009 |
| October 2004 |
| October 2009 (final data collection date for primary outcome measure) |
| Safety of long-term exposure to lacosamide was evaluated with the monitoring of adverse events (AEs), ECGs, vital signs, and clinical laboratory data. [ Time Frame: At periodic clinic visits throughout the trial ] [ Designated as safety issue: No ] |
| Safety of long-term exposure to lacosamide was evaluated with the monitoring of adverse events (AEs), ECGs, vital signs, and clinical laboratory data. [ Time Frame: At periodic clinic visits throughout the trial ] |
| Complete list of historical versions of study NCT00522275 on ClinicalTrials.gov Archive Site |
| Efficacy and maintenance of efficacy with long-term exposure to lacosamide is evaluated based on reduction in seizure frequency, 50 percent reduction in seizures, number and percentage of seizure-free days, and achievement of seizure-free status. [ Time Frame: At periodic clinic visits throughout the trial ] [ Designated as safety issue: No ] |
| Efficacy and maintenance of efficacy with long-term exposure to lacosamide is evaluated based on reduction in seizure frequency, 50 percent reduction in seizures, number and percentage of seizure-free days, and achievement of seizure-free status. [ Time Frame: At periodic clinic visits throughout the trial ] |
| |
| Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures |
| An Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral SPM 927 in Patients With Partial Seizures |
The purpose of this trial is to determine whether lacosamide is safe and effective for long-term use in patients with partial-seizures from epilepsy |
| |
| Phase III |
| Interventional |
| Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Partial Epilepsies |
| Drug: lacosamide |
| Experimental: Up to 800mg/day lacosamide (flexible dosing) |
| |
| |
| Completed |
| 308 |
| October 2009 |
| October 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Completion of parent clinical trial for treatment of partial seizures
Exclusion Criteria:
- Receiving any study drug or experimental device other than lacosamide
- Meets withdrawal criteria for parent trial or experiencing ongoing serious adverse event
|
| Both |
| 16 Years to 70 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00522275 |
| Study Director, UCB |
| SP756 |
| UCB, Inc. |
|
| Study Director: |
UCB Clinical Trial Call Center |
+1 877 822 9493 (UCB) |
|
|
| UCB, Inc. |
| November 2009 |
