Study Evaluating Changes in Total Drug Load and Seizure Frequency Using Vimpat® (Lacosamide) in Combination Therapy (VICTOS)
This study is enrolling participants by invitation only.
Sponsor:
UCB Pharma GmbH
Information provided by (Responsible Party):
UCB, Inc. ( UCB Pharma GmbH )
ClinicalTrials.gov Identifier:
NCT01673282
First received: August 22, 2012
Last updated: May 8, 2013
Last verified: May 2013
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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:
Genetics Home Reference related topics:
autosomal dominant partial epilepsy with auditory features
pyridoxal 5'-phosphate-dependent epilepsy
Drug Information available for:
Lacosamide
U.S. FDA Resources
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
Locations
| Germany | |
| 18 | |
| Berlin, Germany | |
| 24 | |
| Berlin, Germany | |
| 34 | |
| Berlin, Germany | |
| 23 | |
| Bonn, Germany | |
| 11 | |
| Chemnitz, Germany | |
| 25 | |
| Dortmund, Germany | |
| 32 | |
| Dresden, Germany | |
| 21 | |
| Dueren, Germany | |
| 35 | |
| Düsseldorf, Germany | |
| 30 | |
| Essen, Germany | |
| 29 | |
| Goettingen, Germany | |
| 37 | |
| Göttingen, Germany | |
| 12 | |
| Halle, Germany | |
| 19 | |
| Halle, Germany | |
| 02 | |
| Hamm, Germany | |
| 39 | |
| Heidenheim, Germany | |
| 27 | |
| Jena, Germany | |
| 04 | |
| Jülich, Germany | |
| 13 | |
| Kehl-Kork, Germany | |
| 36 | |
| Kiel, Germany | |
| 28 | |
| Köln, Germany | |
| 05 | |
| Leipzig, Germany | |
| 38 | |
| Leipzig, Germany | |
| 26 | |
| Luben, Germany | |
| 01 | |
| München, Germany | |
| 08 | |
| Oranienburg, Germany | |
| 17 | |
| Osnabrück, Germany | |
| 15 | |
| Rüsselsheim, Germany | |
| 31 | |
| Schwarzenbruck, Germany | |
| 16 | |
| Senftenberg, Germany | |
| 10 | |
| Stuttgart, Germany | |
| 09 | |
| Troisdorf, Germany | |
| 14 | |
| 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 | +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: | May 8, 2013 |
| 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 May 19, 2013