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

September 26, 2016 updated by: UCB Pharma GmbH

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

315

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with focal epilepsy with or without secondary generalization.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Lacosamide
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).
Other Names:
  • Vimpat
  • LCM
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.
Drug: Lacosamide
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).
Other Names:
  • Vimpat
  • LCM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

August 22, 2012

First Submitted That Met QC Criteria

August 22, 2012

First Posted (Estimate)

August 27, 2012

Study Record Updates

Last Update Posted (Estimate)

November 15, 2016

Last Update Submitted That Met QC Criteria

September 26, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP1065

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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