N/A
Completed N=311
Study Evaluating Changes in Total Drug Load and Seizure Frequency Using Vimpat® (Lacosamide) in Combination Therapy
Focal Epilepsy With and Without Secondary Generalization
Source: ClinicalTrials.gov NCT01673282 ↗
Enrolled (actual)
311
Serious AEs
2.3%
Results posted
Nov 2016
Primary outcomePrimary: 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) — -15.0; -4.4 percent change of ratio in dose — p==0.0003
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
-15.0; -4.4 | =0.0003 sig |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01673282). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.