Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures - Full Text View

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

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy Seizures

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

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

Criteria

Inclusion Criteria:

Exclusion Criteria:

Receiving any study drug or experimental device other than lacosamide
Meets withdrawal criteria for parent trial or experiencing ongoing serious adverse event

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00522275

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

No publications provided

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

Keywords provided by UCB, Inc.:

Adjunctive treatment in epilepsy
add-on treatment for epilepsy
partial seizures

AEDs
antiepileptic drugs
seizures

Additional relevant MeSH terms:

Epilepsies, Partial
Signs and Symptoms
Epilepsy
Nervous System Diseases

Seizures
Neurologic Manifestations
Central Nervous System Diseases
Brain Diseases

ClinicalTrials.gov processed this record on February 08, 2010