Study Evaluating Changes in Total Drug Load and Seizure Frequency Using Vimpat® (Lacosamide) in Combination Therapy
VICTOS
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
1 other identifier
observational
315
2 countries
42
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2012
Typical duration for all trials
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 22, 2012
CompletedFirst Posted
Study publicly available on registry
August 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedResults Posted
Study results publicly available
November 15, 2016
CompletedNovember 15, 2016
September 1, 2016
3 years
August 22, 2012
June 29, 2016
September 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Drug load is defined as the sum of the ratios of the actual doses divided by the defined daily dose for all concomitant AEDs.
From Baseline (Day 0) to 6 months
Study Arms (2)
Vimpat + Na Channel Blocking AED
Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.
Vimpat + Non-Na Channel Blocking AED
Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.
Interventions
Route of Administration: oral/subcutaneous Form and Dosage: Tablet (50 mg/100 mg/150 mg, 200 mg); Syrup (10 mg/ml); Solution for infusion (10 mg/ml).
Eligibility Criteria
Adult patients with focal epilepsy with or without secondary generalization.
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharma GmbHlead
Study Sites (42)
60
Innsbruck, Austria
61
Mauer bei Amstetten, Austria
63
Ried, Austria
18
Berlin, Germany
34
Berlin, Germany
43
Berlin, Germany
66
Berlin, Germany
23
Bonn, Germany
28
Cologne, Germany
40
Cologne, Germany
25
Dortmund, Germany
35
Düsseldorf, Germany
48
Erbach im Odenwald, Germany
59
Erlangen, Germany
30
Essen, Germany
47
Giessen, Germany
29
Göttingen, Germany
37
Göttingen, 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
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 am Main, Germany
16
Senftenberg, Germany
41
Stuttgart, Germany
09
Troisdorf, Germany
22
Tübingen, Germany
20
Ulm, Germany
07
Westerstede, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB (Study Director)
- Organization
- UCB Cares
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
UCB Pharma
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2012
First Posted
August 27, 2012
Study Start
July 1, 2012
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
November 15, 2016
Results First Posted
November 15, 2016
Record last verified: 2016-09