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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma GmbH )
ClinicalTrials.gov Identifier:
NCT01673282
First received: August 22, 2012
Last updated: May 11, 2015
Last verified: May 2015
  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 Pharma:

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: July 2015
Estimated Primary Completion Date: July 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

Locations
Austria
60
Innsbruck, Austria
61
Mauer bei Amstetten, Austria
63
Ried, Austria
Germany
43
Berlin, Germany
34
Berlin, Germany
66
Berlin, Germany
18
Berlin, Germany
23
Bonn, Germany
25
Dortmund, Germany
35
Duesseldorf, Germany
48
Erbach, Germany
59
Erlangen, Germany
30
Essen, Germany
47
Giessen, Germany
29
Goettingen, Germany
37
Goettingen, Germany
05
Haag, Germany
12
Halle, Germany
19
Halle, Germany
39
Heidenheim, Germany
54
Ibbenbueren, Germany
27
Jena, Germany
04
Jülich, Germany
13
Kehl-Kork, Germany
36
Kiel, Germany
28
Koeln, Germany
40
Koeln, Germany
38
Leipzig, Germany
52
Magdeburg, Germany
67
Mainz, Germany
49
Mittweida, Germany
01
München, Germany
08
Oranienburg, Germany
17
Osnabrück, Germany
14
Radeberg, Germany
15
Rüsselsheim, Germany
16
Senftenberg, Germany
41
Stuttgart, Germany
09
Troisdorf, Germany
22
Tübingen, Germany
20
Ulm, Germany
07
Westerstede, Germany
Sponsors and Collaborators
UCB Pharma GmbH
Investigators
Study Director: UCB Clinical Trial Call Center UCB Pharma
  More Information

No publications provided

Responsible Party: UCB Pharma ( UCB Pharma GmbH )
ClinicalTrials.gov Identifier: NCT01673282     History of Changes
Other Study ID Numbers: SP1065
Study First Received: August 22, 2012
Last Updated: May 11, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Agency for Health and Food Safety

Keywords provided by UCB Pharma:
Lacosamide
Vimpat
Focal Epilepsy
Drug Load
AED
SP1065

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

ClinicalTrials.gov processed this record on June 30, 2015