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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00520741
First received: August 24, 2007
Last updated: December 11, 2012
Last verified: December 2012
  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the efficacy and safety of conversion to lacosamide monotherapy in subjects with partial-onset seizures who are withdrawn from 1 to 2 marketed antiepileptic drugs.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:


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 April 15, 2014