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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacosamide | Drug | 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). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Baseline (Day 0) to 6 months |
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Inclusion Criteria:
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Adult patients with focal epilepsy with or without secondary generalization.
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | UCB Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 60 | Innsbruck | Austria | ||||
| 61 |
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.
This study started to enroll subjects in Austria and Germany in July 2012 and concluded in July 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Vimpat + Non-Na Channel Blocking AED |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Mauer bei Amstetten |
| Austria |
| 63 | Ried | Austria |
| 18 | Berlin | Germany |
| 34 | Berlin | Germany |
| 43 | Berlin | Germany |
| 66 | Berlin | Germany |
| 23 | Bonn | Germany |
| 28 | Cologne | Germany |
| 40 | Cologne | Germany |
| 25 | Dortmund | Germany |
| 35 | Düsseldorf | Germany |
| 48 | Erbach im Odenwald | Germany |
| 59 | Erlangen | Germany |
| 30 | Essen | Germany |
| 47 | Giessen | Germany |
| 29 | Göttingen | Germany |
| 37 | Göttingen | Germany |
| 05 | Haag | Germany |
| 12 | Halle | Germany |
| 19 | Halle | Germany |
| 39 | Heidenheim | Germany |
| 54 | Ibbenbueren | Germany |
| 27 | Jena | Germany |
| 04 | Jülich | Germany |
| 13 | Kehl-Kork | Germany |
| 36 | Kiel | Germany |
| 38 | Leipzig | Germany |
| 52 | Magdeburg | Germany |
| 67 | Mainz | Germany |
| 49 | Mittweida | Germany |
| 01 | München | Germany |
| 08 | Oranienburg | Germany |
| 17 | Osnabrück | Germany |
| 14 | Radeberg | Germany |
| 15 | Rüsselsheim am Main | Germany |
| 16 | Senftenberg | Germany |
| 41 | Stuttgart | Germany |
| 09 | Troisdorf | Germany |
| 22 | Tübingen | Germany |
| 20 | Ulm | Germany |
| 07 | Westerstede | Germany |
Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED. |
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The analysis group for Baseline Characteristics is the Safety Set (SS). The Safety Set consists of all patients who received at least 1 dose of Lacosamide.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total Title |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | 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. | Posted | Mean | Standard Deviation | percent change of ratio in dose | From Baseline (Day 0) to 6 months |
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During the entire study period (day 0 - month 6)
All patients who received at least 1 dose of Lacosamide were included in the SS.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 1 | 153 | 22 | 153 | ||
| EG001 | 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. | 6 | 158 | 9 | 158 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRAv18.0 | Non-systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRAv18.0 | Non-systematic Assessment |
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| Electrocardiogram QT prolonged | Investigations | MedDRAv18.0 | Non-systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRAv18.0 | Non-systematic Assessment |
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| Seizure | Nervous system disorders | MedDRAv18.0 | Non-systematic Assessment |
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| Adverse event | General disorders | MedDRAv18.0 | Non-systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRAv18.0 | Non-systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRAv18.0 | Non-systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRAv18.0 | Non-systematic Assessment |
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| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRAv18.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRAv18.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug ineffective | General disorders | MedDRAv18.0 | Non-systematic Assessment | Adverse event terminology as reported by the investigator. |
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| Off label use | Injury, poisoning and procedural complications | MedDRAv18.0 | Non-systematic Assessment | Adverse event terminology as reported by the investigator. |
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| Overdose | Injury, poisoning and procedural complications | MedDRAv18.0 | Non-systematic Assessment | Overdose was defined as any Vimpat dose that was higher than the maximum approved dose of 400 mg/day. Adverse event terminology as reported by the investigator. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB (Study Director) | UCB Cares | +1 887 822 9493 |
| ID | Term |
|---|---|
| D004828 | Epilepsies, Partial |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000078334 | Lacosamide |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| >=65 years |
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| Male |
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