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)

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

25; 🇩🇪 Dortmund, Germany

35; 🇩🇪 Duesseldorf, Germany

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