Study Evaluating Changes in Total Drug Load and Seizure Frequency Using Vimpat® (Lacosamide) in Combination Therapy (VICTOS)

This study is currently recruiting participants.
Verified April 2014 by UCB, Inc.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc. ( UCB Pharma GmbH )
ClinicalTrials.gov Identifier:
NCT01673282
First received: August 22, 2012
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

This observational study aims to investigate how VIMPAT® is used as adjunctive therapy in clinical practice and will also evaluate the subsequent change in the drug load of patients after addition of VIMPAT® to their treatment regimen.


Condition
Focal Epilepsy With and Without Secondary Generalization

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Non-interventional, Observational Study Evaluating Changes in Drug Load and Seizure Frequency Using Vimpat (Lacosamide) in Daily Clinical Practice in Combination Therapy With Sodium Channel Blocking Anti-epileptic Drugs (AEDs) or Non Sodium Channel Blocking AEDs

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • The percent change in ratio of dose and Defined Daily Dose (DDD) for the drug load of concomitant Anti-Epileptic Drugs (AEDs) from Baseline to the end of Observation Period (Day 0 to 6 months) [ Time Frame: From Baseline (Day 0) to 6 months ] [ Designated as safety issue: No ]
    Drug load is defined as the sum of the ratios of the actual doses divided by the defined daily dose for all concomitant AEDs.


Estimated Enrollment: 374
Study Start Date: July 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
LCM and concomitant sodium channel blocking AEDs
Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.
LCM and concomitant non sodium channel blocking AEDs
Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients with focal epilepsy with or without secondary generalization.

Criteria

Inclusion Criteria:

  • The patient has not received Vimpat® more than 7 days prior to start of Non-Interventional Study (NIS)
  • The patient must have a diagnosis of epilepsy with partial-onset seizures with or without secondary generalization
  • Based on the physician's clinical judgment, it is in the patient's best interest to be prescribed adjunctive Vimpat® (ie, the decision to prescribe Vimpat® is made by the physician)
  • Patient must be at least 18 years of age
  • The patient must have had at least one seizure within the last 3 months prior to enrolment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01673282

Contacts
Contact: UCB Clinical Trial Call Center + 1 887 822 ext 9493

  Show 64 Study Locations
Sponsors and Collaborators
UCB Pharma GmbH
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB, Inc. ( UCB Pharma GmbH )
ClinicalTrials.gov Identifier: NCT01673282     History of Changes
Other Study ID Numbers: SP1065
Study First Received: August 22, 2012
Last Updated: April 10, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Agency for Health and Food Safety

Keywords provided by UCB, Inc.:
Lacosamide
Vimpat
Focal Epilepsy
Drug Load
AED
SP1065

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014