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| Sponsor: | UCB, Inc. |
|---|---|
| Information provided by: | UCB, Inc. |
| ClinicalTrials.gov Identifier: | NCT00522275 |
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Partial Epilepsies |
Drug: lacosamide |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | An Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral SPM 927 in Patients With Partial Seizures |
| Enrollment: | 308 |
| Study Start Date: | October 2004 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Lacosamide: Experimental
Up to 800mg/day lacosamide (flexible dosing)
|
Drug: lacosamide
50mg or 100 mg tablets, up to 800 mg/day given as BID dosing throughout the trial
|
Eligibility| Ages Eligible for Study: | 16 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 63 Study Locations| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
More Information
| Responsible Party: | UCB ( Study Director ) |
| Study ID Numbers: | SP756 |
| Study First Received: | August 27, 2007 |
| Last Updated: | November 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00522275 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Adjunctive treatment in epilepsy add-on treatment for epilepsy partial seizures |
AEDs antiepileptic drugs seizures |
|
Epilepsies, Partial Signs and Symptoms Epilepsy Nervous System Diseases |
Seizures Neurologic Manifestations Central Nervous System Diseases Brain Diseases |