Epilepsies, Partial
Conditions
Keywords
Lacosamide, Vimpat®, Epilepsy, Partial-Onset Seizures, Adjunctive therapy
Brief summary
The purpose of this study is to systematically and prospectively collect data from patients with partial-onset seizures in routine clinical practice setting receiving adjunctive Vimpat®. The observed population will be only patients with one baseline antiepileptic drug. Seizure control and tolerability data will be evaluated.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
* The patient's treatment must be in accordance with the local marketing authorization (MA) for Vimpat® * The decision to prescribe Vimpat® has to be made by the physician before and independently of his/her decision to include the patient in the study * The Vimpat® treatment should have been started not longer than 2 weeks before study inclusion of the patient * The patient must have a diagnosis of Epilepsy with Partial-Onset Seizures * Based on the physician's clinical judgment, the patient's seizure activity is not controlled sufficiently on a current monotherapy and it is in the patient's best interest to be prescribed adjunctive Vimpat®
Exclusion criteria
In accordance with the Summary of Product Characteristics (SmPC)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression of Change (CGI-C) at Month 6 | Month 6 | For the assessment of the Clinical Global Impression of Change (CGI-C), the investigator provided his/her assessment of the subject's clinical status compared to Baseline. He/she was asked to check the category that best describes the subject's condition over the past 6 months compared to Baseline: * Very much improved * Much improved * Minimally improved * No change * Minimally worse * Much worse * Very much worse |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 3 | From Baseline to Month 3 | Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 3 months were normalized to a 28 days interval. Change in number of partial-onset seizures was derived as follows: Change in SF per 28 days = (SF at 3 months per 28 days) - (SF at Baseline per 28 days). A negative value in change from Baseline means that the value has decreased from Baseline to Month 3. Partial-onset seizures can be classified into one of the following three groups: * Simple partial seizures * Complex partial seizures * Partial seizures evolving to secondarily generalized seizures. |
| Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 6 | From Baseline to Month 6 | Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 6 months were normalized to a 28 days interval. Change in number of partial-onset seizures was derived as follows: Change in SF per 28 days = (SF at 6 months per 28 days) - (SF at Baseline per 28 days). A negative value in change from Baseline means that the value has decreased from Baseline to Month 6. Partial-onset seizures can be classified into one of the following three groups: * Simple partial seizures * Complex partial seizures * Partial seizures evolving to secondarily generalized seizures. |
| Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 3 | From Baseline to Month 3 | Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 3 months were normalized to a 28 days interval. Change in number of partial-onset seizures with secondary generalization was derived as follows: Change in SF per 28 days = (SF at 3 months per 28 days) - (SF at Baseline per 28 days). A negative value in change from Baseline means that the value has decreased from Baseline to Month 3. Partial-onset seizures with secondary generalization can be classified into one of the following three groups: * Simple partial seizures evolving to generalized seizures * Complex partial seizures evolving to generalized seizures * Simple partial seizures evolving to Complex partial seizures evolving to generalized seizures. |
| Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 6 | From Baseline to Month 6 | Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 6 months were normalized to a 28 days interval. Change in number of partial-onset seizures with secondary generalization was derived as follows: Change in SF per 28 days = (SF at 6 months per 28 days) - (SF at Baseline per 28 days). A negative value in change from Baseline means that the value has decreased from Baseline to Month 6. Partial-onset seizures with secondary generalization can be classified into one of the following three groups: * Simple partial seizures evolving to generalized seizures * Complex partial seizures evolving to generalized seizures * Simple partial seizures evolving to Complex partial seizures evolving to generalized seizures. |
| Incidence of Adverse Events During the Study | From Inclusion Visit (Day 0) up to Month 6 | The number of subjects affected by any Treatment Emergent Adverse Event (TEAE) during the course of the study from Day 0 up to Month 6 is presented below. |
Countries
Germany
Participant flow
Recruitment details
This observational study started to enroll subjects in March 2010 in order to end up with 113 centers with enrolled subjects in Germany.
Pre-assignment details
Participant Flow refers to the Enrolled Set (ES). The ES comprises all subjects who have been included in the observational study and for whom baseline examination data are available. Three patients were removed from the Enrolled Set after discussion in the Data Review Meeting.
Participants by arm
| Arm | Count |
|---|---|
| Vimpat® Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug. | 520 |
| Total | 520 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 37 |
| Overall Study | Adverse Event & Lack of Efficacy | 6 |
| Overall Study | Adverse Event & Lost to Follow-up | 2 |
| Overall Study | Adverse Event & Wish of Patient | 13 |
| Overall Study | AE & Lack of Efficacy & Wish of Patient | 1 |
| Overall Study | Lack of Efficacy | 4 |
| Overall Study | Lack of Efficacy & Wish of Patient | 5 |
| Overall Study | Lost to Follow-up | 9 |
| Overall Study | Other Reason | 1 |
| Overall Study | Reason Unknown | 26 |
| Overall Study | Wish of Patient | 7 |
| Overall Study | Wish of Patient & Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Vimpat® |
|---|---|
| Age, Continuous | 47.1 years STANDARD_DEVIATION 17 |
| Age, Customized < 16 years | 0 participants |
| Age, Customized >= 16 years to <= 18 years | 7 participants |
| Age, Customized > 18 years to <= 64 years | 419 participants |
| Age, Customized >= 65 years | 94 participants |
| Race/Ethnicity, Customized Arabic | 2 participants |
| Race/Ethnicity, Customized Asiatic | 3 participants |
| Race/Ethnicity, Customized Black African | 0 participants |
| Race/Ethnicity, Customized North/Middle European | 484 participants |
| Race/Ethnicity, Customized Other Race | 3 participants |
| Race/Ethnicity, Customized South European | 28 participants |
| Region of Enrollment Germany | 520 participants |
| Sex: Female, Male Female | 264 Participants |
| Sex: Female, Male Male | 256 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 114 / 571 |
| serious Total, serious adverse events | 56 / 571 |
Outcome results
Clinical Global Impression of Change (CGI-C) at Month 6
For the assessment of the Clinical Global Impression of Change (CGI-C), the investigator provided his/her assessment of the subject's clinical status compared to Baseline. He/she was asked to check the category that best describes the subject's condition over the past 6 months compared to Baseline: * Very much improved * Much improved * Minimally improved * No change * Minimally worse * Much worse * Very much worse
Time frame: Month 6
Population: Of the 520 subjects in the Full Analysis Set (FAS), 515 subjects are included in the analysis of this outcome measure.~FAS comprises all subjects who have been treated with Vimpat® at least once, who fulfill the inclusion criteria and for whom a valid baseline and post-baseline value of seizure frequency is available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vimpat® | Clinical Global Impression of Change (CGI-C) at Month 6 | Very Much Improved | 160 participants |
| Vimpat® | Clinical Global Impression of Change (CGI-C) at Month 6 | Very Much Worse | 2 participants |
| Vimpat® | Clinical Global Impression of Change (CGI-C) at Month 6 | Much Improved | 179 participants |
| Vimpat® | Clinical Global Impression of Change (CGI-C) at Month 6 | Minimally Improved | 66 participants |
| Vimpat® | Clinical Global Impression of Change (CGI-C) at Month 6 | No Change | 72 participants |
| Vimpat® | Clinical Global Impression of Change (CGI-C) at Month 6 | Minimally Worse | 16 participants |
| Vimpat® | Clinical Global Impression of Change (CGI-C) at Month 6 | Much Worse | 9 participants |
| Vimpat® | Clinical Global Impression of Change (CGI-C) at Month 6 | Missing | 11 participants |
Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 3
Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 3 months were normalized to a 28 days interval. Change in number of partial-onset seizures was derived as follows: Change in SF per 28 days = (SF at 3 months per 28 days) - (SF at Baseline per 28 days). A negative value in change from Baseline means that the value has decreased from Baseline to Month 3. Partial-onset seizures can be classified into one of the following three groups: * Simple partial seizures * Complex partial seizures * Partial seizures evolving to secondarily generalized seizures.
Time frame: From Baseline to Month 3
Population: Of the 520 subjects in the Full Analysis Set (FAS), 449 subjects are included in the analysis of this outcome measure.~FAS comprises all subjects who have been treated with Vimpat® at least once, who fulfill the inclusion criteria and for whom a valid baseline and post-baseline value of seizure frequency is available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vimpat® | Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 3 | -3.80 Seizures per 28 days | Standard Deviation 26.23 |
Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 6
Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 6 months were normalized to a 28 days interval. Change in number of partial-onset seizures was derived as follows: Change in SF per 28 days = (SF at 6 months per 28 days) - (SF at Baseline per 28 days). A negative value in change from Baseline means that the value has decreased from Baseline to Month 6. Partial-onset seizures can be classified into one of the following three groups: * Simple partial seizures * Complex partial seizures * Partial seizures evolving to secondarily generalized seizures.
Time frame: From Baseline to Month 6
Population: Of the 520 subjects in the Full Analysis Set (FAS), 500 subjects are included in the analysis of this outcome measure.~FAS comprises all subjects who have been treated with Vimpat® at least once, who fulfill the inclusion criteria and for whom a valid baseline and post-baseline value of seizure frequency is available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vimpat® | Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 6 | -4.24 Seizures per 28 days | Standard Deviation 26.22 |
Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 3
Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 3 months were normalized to a 28 days interval. Change in number of partial-onset seizures with secondary generalization was derived as follows: Change in SF per 28 days = (SF at 3 months per 28 days) - (SF at Baseline per 28 days). A negative value in change from Baseline means that the value has decreased from Baseline to Month 3. Partial-onset seizures with secondary generalization can be classified into one of the following three groups: * Simple partial seizures evolving to generalized seizures * Complex partial seizures evolving to generalized seizures * Simple partial seizures evolving to Complex partial seizures evolving to generalized seizures.
Time frame: From Baseline to Month 3
Population: Of the 520 subjects in the Full Analysis Set (FAS), 447 subjects are included in the analysis of this outcome measure.~FAS comprises all subjects who have been treated with Vimpat® at least once, who fulfill the inclusion criteria and for whom a valid baseline and post-baseline value of seizure frequency is available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vimpat® | Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 3 | -0.39 Seizures per 28 days | Standard Deviation 1.61 |
Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 6
Baseline values for the seizure frequency (SF) during the 12 weeks time period prior to inclusion ('historical baseline'), and the post-baseline values of seizure frequency reported after 6 months were normalized to a 28 days interval. Change in number of partial-onset seizures with secondary generalization was derived as follows: Change in SF per 28 days = (SF at 6 months per 28 days) - (SF at Baseline per 28 days). A negative value in change from Baseline means that the value has decreased from Baseline to Month 6. Partial-onset seizures with secondary generalization can be classified into one of the following three groups: * Simple partial seizures evolving to generalized seizures * Complex partial seizures evolving to generalized seizures * Simple partial seizures evolving to Complex partial seizures evolving to generalized seizures.
Time frame: From Baseline to Month 6
Population: Of the 520 subjects in the Full Analysis Set (FAS), 500 subjects are included in the analysis of this outcome measure.~FAS comprises all subjects who have been treated with Vimpat® at least once, who fulfill the inclusion criteria and for whom a valid baseline and post-baseline value of seizure frequency is available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vimpat® | Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 6 | -0.39 Seizures per 28 days | Standard Deviation 1.88 |
Incidence of Adverse Events During the Study
The number of subjects affected by any Treatment Emergent Adverse Event (TEAE) during the course of the study from Day 0 up to Month 6 is presented below.
Time frame: From Inclusion Visit (Day 0) up to Month 6
Population: All 571 subjects in the Safety Set are included in the analysis of this outcome measure.~Safety Set comprises all patients included who have been treated with Vimpat® at least once.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vimpat® | Incidence of Adverse Events During the Study | 277 participants |