Seizures
Conditions
Keywords
Lacosamide, Vimpat®
Brief summary
Observational study at the request of the Belgian Institut National d'Assurance Maladie-Invalidité / Rijksinstituut voor Ziekte-en Invaliditeits Verzekering INAMI/RIZIV: * type of patient treated with VIMPAT® * VIMPAT® dose * Effect of VIMPAT® on evolution of seizure control * Persistence rate at 6 months in terms of treatment duration * Discontinuation rate * Description of any changes in other epilepsy therapies * Safety and tolerability
Interventions
DRUGLacosamide
Sponsors
UCB Pharma
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form * Subject/legal representative is considered reliable and capable of adhering to the medication intake according to the judgement of the investigator * Based on the investigators clinical judgement, the subjects' seizure activity is uncontrolled on current therapy and it is in the subjects' best interest to be prescribed an antiepileptic drug (AED) as adjunctive therapy. The choice to prescribe VIMPAT® as adjunctive therapy is made by the treating investigator * The subject is aged 16 or older * The subject has a diagnosis of epilepsy with partial-onset seizures according to the label * The subject has a medication history with at least 3 AED therapies (lifetime and/or concomitant) with treatment failure: due to insufficient efficacy, due to significant adverse events * Sufficient data on the clinical situation before start of VIMPAT® and information on VIMPAT® dosing are present in the subject's medical record for patients on treatment with VIMPAT® at the time of enrollment into the study
Exclusion criteria
* The subject has previously participated in this study or has participated in a clinical trial within the last 2 months * The subject has a history of chronic alcohol or drug abuse within the last 6 months * The subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study * The subject has a known hypersensitivity and/or allergy to soya, peanuts, or any component of VIMPAT® * The subject is pregnant or lactating * The subject has a known AV-block degree 2 or 3 * The subject is expected to be insufficiently compliant with contraception. * The subject has a history of suicide attempt, has received professional counseling for suicidal ideation, or is currently experiencing active suicidal ideation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 6 Months | 6 months | VIMPAT is available as tablet and oral solution formulation in Belgium. The use of each galenic formulation will be presented with number of subjects by formulation. |
| Mean Total Daily Dose of VIMPAT® (mg) at Baseline | Baseline | Mean total daily dose at baseline will be only provided for subjects who were already treated by VIMPAT® at Baseline. |
| Mean Total Daily Dose of VIMPAT® (mg) at 3 Months | 3 months | — |
| Mean Total Daily Dose of VIMPAT® (mg) at 6 Months | 6 months | — |
| Galenic Formulation Repartition in Subjects Treated by VIMPAT® at Baseline | Baseline | This outcome will be only provided for subjects who were already treated by VIMPAT® at Baseline. VIMPAT is available as tablet and oral solution formulation in Belgium. The use of each galenic formulation will be presented with number of subjects by formulation. |
| Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 3 Months | 3 months | VIMPAT is available as tablet and oral solution formulation in Belgium. The use of each galenic formulation will be presented with number of subjects by formulation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 6 Months | 6 months | Clinical evolution of seizures following administration of VIMPAT compared to baseline before start of VIMPAT. The evolution of seizure control is subjectively assessed by the investigator on a four categorical scale, with options being 1=worsened, 2=stable, 3=improved, 4=much improved. If seizure control is worse, the investigator will try to document the reason |
| Percentage of Subjects Who Received Concomitant Antiepileptic Drug Treatment | From baseline to study termination (6 months) | Concomitant antiepileptic drug (AED) treatments are defined as treatments which started after or at the date of the first administration of VIMPAT®. |
| Treatment Persistence of VIMPAT® After 6 Months | >=6 months | Treatment persistence is defined as the percentage of subjects being treated under VIMPAT® after a given duration (\>=6 months). |
| Percentage of Subjects by Category of Clinical Evolution of Seizure Control at Baseline | Baseline | This outcome will be only provided for subjects who were already treated by VIMPAT® at Baseline. Clinical evolution of seizures following administration of VIMPAT compared to baseline before start of VIMPAT. The evolution of seizure control is subjectively assessed by the investigator on a four categorical scale, with options being 1=worsened, 2=stable, 3=improved, 4=much improved. If seizure control is worse, the investigator will try to document the reason. |
| Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 3 Months | 3 months | Clinical evolution of seizures following administration of VIMPAT compared to baseline before start of VIMPAT. The evolution of seizure control is subjectively assessed by the investigator on a four categorical scale, with options being 1=worsened, 2=stable, 3=improved, 4=much improved. If seizure control is worse, the investigator will try to document the reason. |
Countries
Belgium
Participant flow
Recruitment details
This observational study began enrollment in September 2010. The last patient visit occurred in March 2012. There were 22 study sites in Belgium.
Pre-assignment details
The Safety Set (SS) and Full Analysis Set (FAS) both consisted of 192 subjects. The SS consisted of all enrolled subjects who received at least one dose of VIMPAT (before or during the study). The FAS consists of all enrolled subjects.
Participants by arm
| Arm | Count |
|---|---|
| Patients Treated With VIMPAT® Prior to Enrollment Patients who started VIMPAT® treatment before enrollment. | 105 |
| Patients Who Started VIMPAT® Treatment on/After Enrollment Patients who started VIMPAT® treatment on/after enrollment. | 87 |
| Total | 192 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 14 |
| Overall Study | Incompliance | 1 | 0 |
| Overall Study | Lack of Efficacy | 6 | 6 |
| Overall Study | Lost to Follow-up | 6 | 1 |
| Overall Study | Planned Visit After End of Study | 0 | 1 |
Baseline characteristics
| Characteristic | Patients Who Started VIMPAT® Treatment on/After Enrollment | Patients Treated With VIMPAT® Prior to Enrollment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 3 Participants | 4 Participants |
| Age, Categorical >=65 years | 5 Participants | 5 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 81 Participants | 97 Participants | 178 Participants |
| Age Continuous | 43.3 years STANDARD_DEVIATION 14 | 40.1 years STANDARD_DEVIATION 13.4 | 41.5 years STANDARD_DEVIATION 13.7 |
| Region of Enrollment Belgium | 87 participants | 105 participants | 192 participants |
| Sex: Female, Male Female | 52 Participants | 60 Participants | 112 Participants |
| Sex: Female, Male Male | 35 Participants | 45 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 74 / 192 |
| serious Total, serious adverse events | 8 / 192 |
Outcome results
Primary
Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 3 Months
VIMPAT is available as tablet and oral solution formulation in Belgium. The use of each galenic formulation will be presented with number of subjects by formulation.
Time frame: 3 months
Population: Of the 192 subjects in the Safety Set (SS), 137 subjects had Vimpat daily dosing information available at the 3-month visit and are included in this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients Treated With VIMPAT® Prior to Enrollment | Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 3 Months | Tablet | 74 participants |
| Patients Treated With VIMPAT® Prior to Enrollment | Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 3 Months | Oral Solution | 0 participants |
| Patients Who Started VIMPAT® Treatment on/After Enrollment | Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 3 Months | Tablet | 63 participants |
| Patients Who Started VIMPAT® Treatment on/After Enrollment | Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 3 Months | Oral Solution | 0 participants |
| Total Population | Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 3 Months | Tablet | 137 participants |
| Total Population | Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 3 Months | Oral Solution | 0 participants |
Primary
Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 6 Months
VIMPAT is available as tablet and oral solution formulation in Belgium. The use of each galenic formulation will be presented with number of subjects by formulation.
Time frame: 6 months
Population: Of the 192 subjects in the Safety Set (SS), 154 subjects had Vimpat dosing data available at the 6-month visit and are included in this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients Treated With VIMPAT® Prior to Enrollment | Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 6 Months | Tablet | 87 participants |
| Patients Treated With VIMPAT® Prior to Enrollment | Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 6 Months | Oral Solution | 0 participants |
| Patients Who Started VIMPAT® Treatment on/After Enrollment | Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 6 Months | Tablet | 67 participants |
| Patients Who Started VIMPAT® Treatment on/After Enrollment | Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 6 Months | Oral Solution | 0 participants |
| Total Population | Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 6 Months | Tablet | 154 participants |
| Total Population | Galenic Formulation Repartition in Subjects Treated by VIMPAT® at 6 Months | Oral Solution | 0 participants |
Primary
Galenic Formulation Repartition in Subjects Treated by VIMPAT® at Baseline
This outcome will be only provided for subjects who were already treated by VIMPAT® at Baseline. VIMPAT is available as tablet and oral solution formulation in Belgium. The use of each galenic formulation will be presented with number of subjects by formulation.
Time frame: Baseline
Population: Of the 192 subjects in the Safety Set (SS), 105 subjects were treated with Vimpat at Baseline are included in this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients Treated With VIMPAT® Prior to Enrollment | Galenic Formulation Repartition in Subjects Treated by VIMPAT® at Baseline | Tablet | 104 participants |
| Patients Treated With VIMPAT® Prior to Enrollment | Galenic Formulation Repartition in Subjects Treated by VIMPAT® at Baseline | Oral Solution | 1 participants |
Primary
Mean Total Daily Dose of VIMPAT® (mg) at 3 Months
Time frame: 3 months
Population: Of the 192 subjects in the Safety Set (SS), 137 subjects had Vimpat daily dosing information available at the 3-month visit and are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Treated With VIMPAT® Prior to Enrollment | Mean Total Daily Dose of VIMPAT® (mg) at 3 Months | 316.2 mg/day of Vimpat | Standard Deviation 106.7 |
| Patients Who Started VIMPAT® Treatment on/After Enrollment | Mean Total Daily Dose of VIMPAT® (mg) at 3 Months | 211.1 mg/day of Vimpat | Standard Deviation 77.4 |
| Total Population | Mean Total Daily Dose of VIMPAT® (mg) at 3 Months | 267.9 mg/day of Vimpat | Standard Deviation 107.7 |
Primary
Mean Total Daily Dose of VIMPAT® (mg) at 6 Months
Time frame: 6 months
Population: Of the 192 subjects in the Safety Set (SS), 154 subjects had Vimpat dosing data available at the 6-month visit and are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Treated With VIMPAT® Prior to Enrollment | Mean Total Daily Dose of VIMPAT® (mg) at 6 Months | 329.9 mg/day of Vimpat | Standard Deviation 119.5 |
| Patients Who Started VIMPAT® Treatment on/After Enrollment | Mean Total Daily Dose of VIMPAT® (mg) at 6 Months | 262.7 mg/day of Vimpat | Standard Deviation 103.9 |
| Total Population | Mean Total Daily Dose of VIMPAT® (mg) at 6 Months | 300.6 mg/day of Vimpat | Standard Deviation 117.5 |
Primary
Mean Total Daily Dose of VIMPAT® (mg) at Baseline
Mean total daily dose at baseline will be only provided for subjects who were already treated by VIMPAT® at Baseline.
Time frame: Baseline
Population: Of the 192 subjects in the Safety Set (SS), 105 subjects were treated with Vimpat at Baseline are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Treated With VIMPAT® Prior to Enrollment | Mean Total Daily Dose of VIMPAT® (mg) at Baseline | 272.1 mg/day of Vimpat | Standard Deviation 114.4 |
Secondary
Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 3 Months
Clinical evolution of seizures following administration of VIMPAT compared to baseline before start of VIMPAT. The evolution of seizure control is subjectively assessed by the investigator on a four categorical scale, with options being 1=worsened, 2=stable, 3=improved, 4=much improved. If seizure control is worse, the investigator will try to document the reason.
Time frame: 3 months
Population: Of the 192 subjects in the Safety Set (SS), 152 subjects had Vimpat daily dosing information available at the 3-month visit and are included in this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients Treated With VIMPAT® Prior to Enrollment | Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 3 Months | Much improved | 16.7 percentage of participants |
| Patients Treated With VIMPAT® Prior to Enrollment | Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 3 Months | Worsened | 5.1 percentage of participants |
| Patients Treated With VIMPAT® Prior to Enrollment | Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 3 Months | Stable | 34.6 percentage of participants |
| Patients Treated With VIMPAT® Prior to Enrollment | Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 3 Months | Unknown | 0 percentage of participants |
| Patients Treated With VIMPAT® Prior to Enrollment | Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 3 Months | Improved | 43.6 percentage of participants |
| Patients Who Started VIMPAT® Treatment on/After Enrollment | Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 3 Months | Unknown | 5.4 percentage of participants |
| Patients Who Started VIMPAT® Treatment on/After Enrollment | Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 3 Months | Much improved | 16.2 percentage of participants |
| Patients Who Started VIMPAT® Treatment on/After Enrollment | Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 3 Months | Improved | 33.8 percentage of participants |
| Patients Who Started VIMPAT® Treatment on/After Enrollment | Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 3 Months | Stable | 35.1 percentage of participants |
| Patients Who Started VIMPAT® Treatment on/After Enrollment | Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 3 Months | Worsened | 9.5 percentage of participants |
| Total Population | Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 3 Months | Improved | 38.8 percentage of participants |
| Total Population | Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 3 Months | Unknown | 2.7 percentage of participants |
| Total Population | Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 3 Months | Worsened | 7.2 percentage of participants |
| Total Population | Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 3 Months | Much improved | 16.4 percentage of participants |
| Total Population | Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 3 Months | Stable | 34.9 percentage of participants |
Secondary
Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 6 Months
Clinical evolution of seizures following administration of VIMPAT compared to baseline before start of VIMPAT. The evolution of seizure control is subjectively assessed by the investigator on a four categorical scale, with options being 1=worsened, 2=stable, 3=improved, 4=much improved. If seizure control is worse, the investigator will try to document the reason
Time frame: 6 months
Population: Of the 192 subjects in the Safety Set (SS), 168 subjects had Vimpat dosing data available at the 6-month visit and are included in this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients Treated With VIMPAT® Prior to Enrollment | Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 6 Months | Much improved | 18.9 percentage of participants |
| Patients Treated With VIMPAT® Prior to Enrollment | Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 6 Months | Improved | 35.8 percentage of participants |
| Patients Treated With VIMPAT® Prior to Enrollment | Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 6 Months | Stable | 40.0 percentage of participants |
| Patients Treated With VIMPAT® Prior to Enrollment | Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 6 Months | Worsened | 5.3 percentage of participants |
| Patients Who Started VIMPAT® Treatment on/After Enrollment | Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 6 Months | Worsened | 8.2 percentage of participants |
| Patients Who Started VIMPAT® Treatment on/After Enrollment | Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 6 Months | Much improved | 19.2 percentage of participants |
| Patients Who Started VIMPAT® Treatment on/After Enrollment | Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 6 Months | Stable | 34.2 percentage of participants |
| Patients Who Started VIMPAT® Treatment on/After Enrollment | Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 6 Months | Improved | 38.4 percentage of participants |
| Total Population | Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 6 Months | Worsened | 6.5 percentage of participants |
| Total Population | Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 6 Months | Improved | 36.9 percentage of participants |
| Total Population | Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 6 Months | Stable | 37.5 percentage of participants |
| Total Population | Percentage of Subjects by Category of Clinical Evolution of Seizure Control at 6 Months | Much improved | 19.0 percentage of participants |
Secondary
Percentage of Subjects by Category of Clinical Evolution of Seizure Control at Baseline
This outcome will be only provided for subjects who were already treated by VIMPAT® at Baseline. Clinical evolution of seizures following administration of VIMPAT compared to baseline before start of VIMPAT. The evolution of seizure control is subjectively assessed by the investigator on a four categorical scale, with options being 1=worsened, 2=stable, 3=improved, 4=much improved. If seizure control is worse, the investigator will try to document the reason.
Time frame: Baseline
Population: Of the 192 subjects in the Safety Set (SS), 105 subjects were treated with Vimpat at Baseline are included in this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients Treated With VIMPAT® Prior to Enrollment | Percentage of Subjects by Category of Clinical Evolution of Seizure Control at Baseline | Much Improved | 16.2 percentage of participants |
| Patients Treated With VIMPAT® Prior to Enrollment | Percentage of Subjects by Category of Clinical Evolution of Seizure Control at Baseline | Improved | 39.0 percentage of participants |
| Patients Treated With VIMPAT® Prior to Enrollment | Percentage of Subjects by Category of Clinical Evolution of Seizure Control at Baseline | Stable | 30.5 percentage of participants |
| Patients Treated With VIMPAT® Prior to Enrollment | Percentage of Subjects by Category of Clinical Evolution of Seizure Control at Baseline | Worsened | 2.9 percentage of participants |
| Patients Treated With VIMPAT® Prior to Enrollment | Percentage of Subjects by Category of Clinical Evolution of Seizure Control at Baseline | Unknown | 11.4 percentage of participants |
Secondary
Percentage of Subjects Who Received Concomitant Antiepileptic Drug Treatment
Concomitant antiepileptic drug (AED) treatments are defined as treatments which started after or at the date of the first administration of VIMPAT®.
Time frame: From baseline to study termination (6 months)
Population: Of the 192 subjects in the Safety Set (SS), 192 are included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Treated With VIMPAT® Prior to Enrollment | Percentage of Subjects Who Received Concomitant Antiepileptic Drug Treatment | 98.1 percentage of patients |
| Patients Who Started VIMPAT® Treatment on/After Enrollment | Percentage of Subjects Who Received Concomitant Antiepileptic Drug Treatment | 96.6 percentage of patients |
| Total Population | Percentage of Subjects Who Received Concomitant Antiepileptic Drug Treatment | 97.4 percentage of patients |
Secondary
Treatment Persistence of VIMPAT® After 6 Months
Treatment persistence is defined as the percentage of subjects being treated under VIMPAT® after a given duration (\>=6 months).
Time frame: >=6 months
Population: Of the 192 subjects in the Safety Set (SS), 192 are included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Treated With VIMPAT® Prior to Enrollment | Treatment Persistence of VIMPAT® After 6 Months | 95.2 percentage of participants |
| Patients Who Started VIMPAT® Treatment on/After Enrollment | Treatment Persistence of VIMPAT® After 6 Months | 56.3 percentage of participants |
| Total Population | Treatment Persistence of VIMPAT® After 6 Months | 77.6 percentage of participants |