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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 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: July 24, 2014
Last verified: July 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: May 2015
Estimated Primary Completion Date: May 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 24, 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
Lacosamide
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014