To Determine Tolerability and Efficacy of Long-Term Oral Lacosamide in Patients With Partial Seizures - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00552305

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 II

MedlinePlus related topics: Epilepsy Seizures

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 Tolerability and Efficacy of Long-Term Oral SPM 927 as Adjunctive Therapy in Patients With Partial Seizures

Further study details as provided by UCB:

Primary Outcome Measures:

Safety of long-term exposure to lacosamide was evaluated with the monitoring of adverse events (AEs), ECGs, vital signs, clinical laboratory data and subject withdrawal to AE. [ Time Frame: At clinical visits every 6-months throughout the trial ]

Secondary Outcome Measures:

Efficacy and maintenance of efficacy with long-term exposure to lacosamide is evaluated based on reduction in seizure frequency, 50 and 75 percent reduction in seizures, percentage of seizure-free days, and achievement of seizure-free status. [ Time Frame: At clinical visits every 6-months throughout the trial. ]
Clinical Global Impression of Change and Quality of Life assessment is also completed. [ Time Frame: At clinic visits every 6-months throughout the trial. ]

Estimated Enrollment:	500
Study Start Date:	August 2001
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Up to 800mg/day lacosamide (flexible dosing)	Drug: lacosamide 50mg and 100mg tablets up to 800 mg/day as bid dosing throughout the trial

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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: NCT00552305

Sponsors and Collaborators

UCB

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	SP615
Study First Received:	October 30, 2007
Last Updated:	October 10, 2008
ClinicalTrials.gov Identifier:	NCT00552305
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Lithuania: State Medicine Control Agency - Ministry of Health; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Epilepsies, Partial
Epilepsy
Seizures
Central Nervous System Diseases
Brain Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009