Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures - Full Text View

Sponsor:	UCB, Inc.
Information provided by:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00520741

Purpose

The objective of this historical-controlled trial is to demonstrate the efficacy and safety of conversion to lacosamide monotherapy in subjects with partial-onset seizures who are withdrawn from 1 to 2 marketed antiepileptic drugs.

Condition	Intervention	Phase
Epilepsy	Drug: lacosamide	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Historical-controlled, Multicenter, Double-blind, Randomized Trial to Assess the Efficacy and Safety of Conversion to Lacosamide 400mg/Day Monotherapy in Subjects With Partial-onset Seizures

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

The primary outcome is the percentage of subjects who are identified as meeting at least 1 pre-defined exit criteria by Day 112 relative to the start of withdrawal of background antiepileptic drug(s). [ Time Frame: 16 weeks (112 days) maintenance phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to first occurrence of any exit event [ Time Frame: 16 weeks (112 days) maintenance phase ] [ Designated as safety issue: No ]
Sum of the exit event rate [ Time Frame: 16 weeks (112 days) maintenance phase ] [ Designated as safety issue: No ]
Withdrawal due to AE rate [ Time Frame: 16 weeks (112 days) maintenance phase ] [ Designated as safety issue: No ]
Withdrawal due to lack of efficacy rate [ Time Frame: 16 weeks (112 days) maintenance phase ] [ Designated as safety issue: No ]
Duration of monotherapy treatment(days) during the Maintenance Phase [ Time Frame: 16 weeks (112 days) maintenance phase ] [ Designated as safety issue: No ]

Estimated Enrollment:	357
Study Start Date:	August 2007
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Lacosamide 400mg: Experimental lacosamide 400mg/day	Drug: lacosamide 50 mg and 100 mg tablets provided for 200mg twice daily dosing for up to 18 weeks.
Lacosamide 300mg: Active Comparator lacosamide 300 mg/day	Drug: lacosamide 50 mg and 100 mg tablets provided for 150mg twice daily dosing for up to 19 weeks.

Eligibility

Ages Eligible for Study:	16 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject has a diagnosis of epilepsy with simple partial seizures (motor component) and or complex partial seizures (with or without secondary generalization)
Must be experiencing 2 to 40 seizures per 28-day period
Stable dose of 1 or 2 marketed antiepileptic drugs
Second AED must be less than or equal to 50% of the minimum effective dose per US product label at screening

Exclusion Criteria:

Subject has a history of primary generalized or unclassified seizures
Seizure disorder primarily characterized by isolated auras
History of status epilepticus
Seizures that are uncountable due to clustering
Has greater than 5 seizures/day
Subjects taking benzodiazepines, phenobarbital or primidone
Subject has VNS
Significant medical or psychiatric condition
History of alcohol or drug abuse
History of ethosuximide use, felbamate use after 1994 or vigabatrin use after 1997

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520741

Contacts

Contact: UCB Clinical Trial Call Center

+877 822 9493

Show 115 Study Locations

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:	SP902
Study First Received:	August 24, 2007
Last Updated:	January 20, 2010
ClinicalTrials.gov Identifier:	NCT00520741 History of Changes
Health Authority:	United States: Food and Drug Administration; Portugal: National Pharmacy and Medicines Institute; Switzerland: Swissmedic; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Spain: Spanish Agency of Medicines; Denmark: Danish Medicines Agency; Austria: Agency for Health and Food Safety; Ireland: Irish Medicines Board; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Netherlands: Medicines Evaluation Board (MEB); Canada: Health Canada; Australia: Department of Health and Ageing Therapeutic Goods Administration; Italy: Ministry of Health; France: Afssaps - French Health Products Safety Agency

Keywords provided by UCB, Inc.:

Epilepsy
partial onset seizures
lacosamide
monotherapy
Vimpat

Additional relevant MeSH terms:

Epilepsy
Nervous System Diseases
Central Nervous System Diseases
Brain Diseases

ClinicalTrials.gov processed this record on February 08, 2010