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

Completed

• Conditions: Focal Epilepsy With and Without Secondary Generalization
• Interventions: Drug: Lacosamide

• Registration Number: NCT01673282
• Lead Sponsor: UCB Pharma GmbH

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-08-22
• Study First Submitted QC: 2012-08-22
• Study First Posted: 2012-08-27
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Results First Submitted: 2016-06-29
• Status Verified: 2016-09
• Results First Submitted QC: 2016-09-26
• Last Update Submitted: 2016-09-26
• Results First Posted: 2016-11-15
• Last Update Posted: 2016-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 315

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vimpat + Na Channel Blocking AED	Lacosamide	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	Lacosamide	Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.

Primary Outcome Measures

Name	Time	Method
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)	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.

Trial Locations

Locations (42)

17; 🇩🇪 Osnabrück, Germany

14; 🇩🇪 Radeberg, Germany

13; 🇩🇪 Kehl-Kork, Germany

36; 🇩🇪 Kiel, Germany

67; 🇩🇪 Mainz, Germany

37; 🇩🇪 Goettingen, Germany

05; 🇩🇪 Haag, Germany

28; 🇩🇪 Koeln, Germany

43; 🇩🇪 Berlin, Germany

25; 🇩🇪 Dortmund, Germany

48; 🇩🇪 Erbach, Germany

59; 🇩🇪 Erlangen, Germany

04; 🇩🇪 Jülich, Germany

16; 🇩🇪 Senftenberg, Germany

63; 🇦🇹 Ried, Austria

38; 🇩🇪 Leipzig, Germany

35; 🇩🇪 Duesseldorf, Germany

47; 🇩🇪 Giessen, Germany

23; 🇩🇪 Bonn, Germany

12; 🇩🇪 Halle, Germany

29; 🇩🇪 Goettingen, Germany

54; 🇩🇪 Ibbenbueren, Germany

19; 🇩🇪 Halle, Germany

39; 🇩🇪 Heidenheim, Germany

52; 🇩🇪 Magdeburg, Germany

60; 🇦🇹 Innsbruck, Austria

09; 🇩🇪 Troisdorf, Germany

07; 🇩🇪 Westerstede, Germany

27; 🇩🇪 Jena, Germany

01; 🇩🇪 München, Germany

20; 🇩🇪 Ulm, Germany

15; 🇩🇪 Rüsselsheim, Germany

22; 🇩🇪 Tübingen, Germany

18; 🇩🇪 Berlin, Germany

34; 🇩🇪 Berlin, Germany

66; 🇩🇪 Berlin, Germany

30; 🇩🇪 Essen, Germany

61; 🇦🇹 Mauer bei Amstetten, Austria

40; 🇩🇪 Koeln, Germany

49; 🇩🇪 Mittweida, Germany

08; 🇩🇪 Oranienburg, Germany

41; 🇩🇪 Stuttgart, Germany