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Observational study at the request of the Belgian Institut National d'Assurance Maladie-Invalidité / Rijksinstituut voor Ziekte-en Invaliditeits Verzekering INAMI/RIZIV:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vimpat® treatment | Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacosamide | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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. | Baseline |
| 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. | 3 months |
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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®. | From baseline to study termination (6 months) |
| Treatment Persistence of VIMPAT® After 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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Routine clinical practice of neurologist / neuropsychiatrist / neurosurgeon / neuropediatrician Sampling based upon request by the Belgian reimbursement authorities: request to report on 100 patients
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalst | Belgium | |||||
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.
This observational study began enrollment in September 2010. The last patient visit occurred in March 2012. There were 22 study sites in Belgium.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Treated With VIMPAT® Prior to Enrollment | Patients who started VIMPAT® treatment before enrollment. |
| FG001 | Patients Who Started VIMPAT® Treatment on/After Enrollment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Treatment persistence is defined as the percentage of subjects being treated under VIMPAT® after a given duration (>=6 months). |
| >=6 months |
| 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. | Baseline |
| 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. | 3 months |
| 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 | 6 months |
| Antwerp |
| Belgium |
| Assebroek | Belgium |
| Bruges | Belgium |
| Brussels | Belgium |
| Charleroi | Belgium |
| Duffel | Belgium |
| Ghent | Belgium |
| Hasselt | Belgium |
| La Louvière | Belgium |
| Leuven | Belgium |
| Liège | Belgium |
| Marche-en-Famenne | Belgium |
| Mons | Belgium |
| Montegnée - Liege | Belgium |
| Ottignies-Louvain-la-Neuve | Belgium |
| Yvoir | Belgium |
Patients who started VIMPAT® treatment on/after enrollment.
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Safety Set (SS) consists of all enrolled subjects who received at least one dose of VIMPAT® (before or during the study).
The SS was used to analyze demographic data and baseline characteristics.
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Treated With VIMPAT® Prior to Enrollment | Patients who started VIMPAT® treatment before enrollment. |
| BG001 | Patients Who Started VIMPAT® Treatment on/After Enrollment | Patients who started VIMPAT® treatment on/after enrollment. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Of the 192 subjects in the Safety Set (SS), 105 subjects were treated with Vimpat at Baseline are included in this analysis. | Posted | Mean | Standard Deviation | mg/day of Vimpat | Baseline |
|
|
| |||||||||||||||||||||||||
| Primary | Mean Total Daily Dose of VIMPAT® (mg) at 3 Months | 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. | Posted | Mean | Standard Deviation | mg/day of Vimpat | 3 months |
|
| |||||||||||||||||||||||||||
| Primary | Mean Total Daily Dose of VIMPAT® (mg) at 6 Months | 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. | Posted | Mean | Standard Deviation | mg/day of Vimpat | 6 months |
|
| |||||||||||||||||||||||||||
| 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. | Of the 192 subjects in the Safety Set (SS), 105 subjects were treated with Vimpat at Baseline are included in this analysis. | Posted | Number | participants | Baseline |
|
| |||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | participants | 3 months |
|
| |||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | participants | 6 months |
|
| |||||||||||||||||||||||||||
| 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®. | Of the 192 subjects in the Safety Set (SS), 192 are included in this analysis. | Posted | Number | percentage of patients | From baseline to study termination (6 months) |
|
| |||||||||||||||||||||||||||
| 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). | Of the 192 subjects in the Safety Set (SS), 192 are included in this analysis. | Posted | Number | percentage of participants | >=6 months |
|
| |||||||||||||||||||||||||||
| 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. | Of the 192 subjects in the Safety Set (SS), 105 subjects were treated with Vimpat at Baseline are included in this analysis. | Posted | Number | percentage of participants | Baseline |
|
| |||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | percentage of participants | 3 months |
| ||||||||||||||||||||||||||||
| 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 | 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. | Posted | Number | percentage of participants | 6 months |
|
Adverse Events (AEs) were collected during the course of the trial, which was approximately 2 years.
Adverse Events refer to the Safety Set (SS). The Safety Set (SS) consisted of all subjects who were randomized and received at least 1 dose of study medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vimpat® Treatment | Reported Adverse Events is a combination of both patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® treatment on/after enrollment. | 8 | 192 | 74 | 192 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Meningitis herpes | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (9.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Gastrointestinal hypermotility | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Procedural headache | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Dysphasia | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Facial paresis | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| VIth nerve paralysis | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (9.1) | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Depressive symptom | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Acute stress disorder | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Conduct disorder | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Decreased interest | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Initial insomnia | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Middle insomnia | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Obsessive-compulsive disorder | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Sleep walking | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (9.1) | Non-systematic Assessment |
|
UCB has > 60 but <= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that the results shall be published regardless of outcome.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB (Study Director) | UCB Clinical Trial Call Center | +1 887 822 9493 |
| ID | Term |
|---|---|
| D012640 | Seizures |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078334 | Lacosamide |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
Not provided
Not provided
| >=65 years |
|
| Male |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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