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

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the efficacy and safety of conversion to lacosamide monotherapy in subjects with partial-onset seizures who are withdrawn from 1 to 2 marketed antiepileptic drugs.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 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Lacosamide

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

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 Maintenance Period (approximately 112 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to First Occurrence of Any Exit Event During The Maintenance Period [ Time Frame: 16 Weeks Maintenance Period (approximately 112 days) ] [ Designated as safety issue: No ]
Sum of The Exit Event Rate During The Maintenance Period [ Time Frame: 16 Weeks Maintenance Period (approximately 112 days) ] [ Designated as safety issue: No ]
Subject Withdrawal Due To Treatment-emergent Adverse Event (TEAE) Rate During Maintenance Period [ Time Frame: 16 Weeks Maintenance Period (approximately 112 days) ] [ Designated as safety issue: No ]
A Treatment-emergent Adverse event (TEAE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Phases.

An TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design).
Subject Withdrawals Due To Lack of Efficacy Rate During The Maintenance Period [ Time Frame: 16 Weeks Maintenance Period (approximately 112 days) ] [ Designated as safety issue: No ]
Duration of Monotherapy Treatment During the Monotherapy Phase of The Maintenance Period (Visit 9 - Visit 12) [ Time Frame: Visit 9 - Visit 12 (approximately 10 weeks) ] [ Designated as safety issue: No ]
Clinical Global Impression of Change (CGIC) From Baseline To Last Visit [ Time Frame: Baseline; Last Visit (approximately 27 weeks) ] [ Designated as safety issue: No ]
The CGIC is a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.
Patient's Global Impression of Change (PGIC) From Baseline To Last Visit [ Time Frame: Baseline; Last Visit (approximately 27 weeks) ] [ Designated as safety issue: No ]
The PGIC is defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected.

Enrollment:	427
Study Start Date:	August 2007
Study Completion Date:	December 2012
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Lacosamide 400 mg Lacosamide 400 mg/day	Drug: Lacosamide 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks. Other Name: Vimpat
Active Comparator: Lacosamide 300 mg Lacosamide 300 mg/day	Drug: Lacosamide 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks. Other Name: Vimpat

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 Antiepileptic Drug (AED) must be less than or equal to 50 % of the minimum recommended maintenance dose per USA 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 Vagus Nerve Stimulation (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

Show 158 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, Inc.
ClinicalTrials.gov Identifier:	NCT00520741 History of Changes
Obsolete Identifiers:	NCT01058954
Other Study ID Numbers:	SP902
Study First Received:	August 24, 2007
Last Updated:	December 11, 2012
Health Authority:	United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency Spain: Spanish Agency of Medicines Denmark: Danish Medicines Agency Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Canada: Health Canada Australia: Department of Health and Ageing Therapeutic Goods Administration Italy: Ministry of Health France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by UCB, Inc.:

Epilepsy
Partial Onset Seizures
Lacosamide
Monotherapy
Vimpat

Additional relevant MeSH terms:

Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013

Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures (ALEX-MT)