Focal Epilepsy With and Without Secondary Generalization
Conditions
Keywords
Lacosamide, Vimpat, Focal Epilepsy, Drug Load, AED, SP1065
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.
Interventions
DRUGLacosamide
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).
Sponsors
UCB Pharma GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Austria, Germany
Participant flow
Recruitment details
This study started to enroll subjects in Austria and Germany in July 2012 and concluded in July 2015.
Pre-assignment details
The Participant Flow consists of subjects in the Safety Set (SS) which received at least 1 dose of VIMPAT. Of the 315 enrolled subjects 311 were included in the SS.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 153 |
| 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. | 158 |
| Total Title | 311 |
| Total | 622 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Drug Reaction - Vimpat | 9 | 5 |
| Overall Study | Lack of Efficacy | 9 | 2 |
| Overall Study | Lost to Follow-up | 11 | 10 |
| Overall Study | Other | 1 | 6 |
| Overall Study | Withdrawal by Subject | 3 | 3 |
Baseline characteristics
| Characteristic | Vimpat + Na Channel Blocking AED | Vimpat + Non-Na Channel Blocking AED | Total Title |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 17 Participants | 41 Participants | 58 Participants |
| Age, Categorical Between 18 and 65 years | 135 Participants | 117 Participants | 252 Participants |
| Age, Continuous | 44.0 years STANDARD_DEVIATION 16.4 | 52.5 years STANDARD_DEVIATION 16 | 48.3 years STANDARD_DEVIATION 16.7 |
| Sex: Female, Male Female | 79 Participants | 66 Participants | 145 Participants |
| Sex: Female, Male Male | 74 Participants | 92 Participants | 166 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 22 / 153 | 9 / 158 |
| serious Total, serious adverse events | 1 / 153 | 6 / 158 |
Outcome results
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)
Drug load is defined as the sum of the ratios of the actual doses divided by the defined daily dose for all concomitant AEDs.
Time frame: From Baseline (Day 0) to 6 months
Population: The analysis group for the outcome measure is the Full Analysis Set (FAS). The FAS included all patients who received at least 1 dose of Lacosamide and for whom at least 1 valid ratio of dose and DDD at Baseline and post-Baseline could be calculated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vimpat + Na Channel Blocking AED | 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 percent change of ratio in dose | Standard Deviation 64.8 |
| Vimpat + Non-Na Channel Blocking AED | 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) | -4.4 percent change of ratio in dose | Standard Deviation 31.9 |
Comparison: Based on an ANCOVA model for absolute change in ratio of dose and DDD with group as a fixed effect and the ratio of dose and DDD at Baseline as a covariate.p-value: =0.000395% CI: [-0.36, -0.11]ANCOVA