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Vimpat® Added as Adjunctive Therapy to One Baseline Antiepileptic Drug

A Non-interventional Post-marketing Study, Evaluating Seizure Control and Tolerability of Vimpat® as Adjunctive Therapy to One Baseline Antiepileptic Drug in Epilepsy Patients With Partial-onset Seizures With or Without Secondary Generalization in Daily Clinical Practice in Germany

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01098162
Acronym
VITOBA
Enrollment
576
Registered
2010-04-02
Start date
2010-03-31
Completion date
2013-07-31
Last updated
2014-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsies, Partial

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

UCB Pharma GmbH
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Clinical Global Impression of Change (CGI-C) at Month 6Month 6For 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

MeasureTime frameDescription
Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 3From Baseline to Month 3Baseline 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 6From Baseline to Month 6Baseline 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 3From Baseline to Month 3Baseline 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 6From Baseline to Month 6Baseline 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 StudyFrom Inclusion Visit (Day 0) up to Month 6The 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

ArmCount
Vimpat®
Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
520
Total520

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyAdverse Event37
Overall StudyAdverse Event & Lack of Efficacy6
Overall StudyAdverse Event & Lost to Follow-up2
Overall StudyAdverse Event & Wish of Patient13
Overall StudyAE & Lack of Efficacy & Wish of Patient1
Overall StudyLack of Efficacy4
Overall StudyLack of Efficacy & Wish of Patient5
Overall StudyLost to Follow-up9
Overall StudyOther Reason1
Overall StudyReason Unknown26
Overall StudyWish of Patient7
Overall StudyWish of Patient & Lost to Follow-up1

Baseline characteristics

CharacteristicVimpat®
Age, Continuous47.1 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 typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
114 / 571
serious
Total, serious adverse events
56 / 571

Outcome results

Primary

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.

ArmMeasureGroupValue (NUMBER)
Vimpat®Clinical Global Impression of Change (CGI-C) at Month 6Very Much Improved160 participants
Vimpat®Clinical Global Impression of Change (CGI-C) at Month 6Very Much Worse2 participants
Vimpat®Clinical Global Impression of Change (CGI-C) at Month 6Much Improved179 participants
Vimpat®Clinical Global Impression of Change (CGI-C) at Month 6Minimally Improved66 participants
Vimpat®Clinical Global Impression of Change (CGI-C) at Month 6No Change72 participants
Vimpat®Clinical Global Impression of Change (CGI-C) at Month 6Minimally Worse16 participants
Vimpat®Clinical Global Impression of Change (CGI-C) at Month 6Much Worse9 participants
Vimpat®Clinical Global Impression of Change (CGI-C) at Month 6Missing11 participants
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Vimpat®Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 3-3.80 Seizures per 28 daysStandard Deviation 26.23
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Vimpat®Change in Number (Frequency) of Partial-onset Seizures Without Secondary Generalization From Baseline to Month 6-4.24 Seizures per 28 daysStandard Deviation 26.22
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Vimpat®Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 3-0.39 Seizures per 28 daysStandard Deviation 1.61
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
Vimpat®Change in Number (Frequency) of Seizures With Secondary Generalization From Baseline to Month 6-0.39 Seizures per 28 daysStandard Deviation 1.88
Secondary

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.

ArmMeasureValue (NUMBER)
Vimpat®Incidence of Adverse Events During the Study277 participants

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026