An observational study in Focal Epilepsy With and Without Secondary Generalization, sponsored by UCB Pharma GmbH. Completed at 42 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-15.
Sponsored by UCB Pharma GmbH · Observational
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.
1,804 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's enrollment of 315 is above the median of 102 across 521 observational studies indexed under Epilepsy.
Browse Epilepsy studies →UCB Pharma GmbH is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Adult patients with focal epilepsy with or without secondary generalization.
Inclusion Criteria:
Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.
Drug: Lacosamide
Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.
Drug: Lacosamide
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).
Also known as: Vimpat, LCM
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.
Time frame: From Baseline (Day 0) to 6 months
This study started to enroll subjects in Austria and Germany in July 2012 and concluded in July 2015.
| Milestone | Vimpat + Na Channel Blocking AED | Vimpat + Non-Na Channel Blocking AED |
|---|---|---|
| Started | 153 | 158 |
| Completed | 120 | 132 |
| Not completed | 33 | 26 |
| Withdrew: Adverse drug reaction - vimpat | 9 | 5 |
| Withdrew: Lack of efficacy | 9 | 2 |
| Withdrew: Lost to follow-up | 11 | 10 |
| Withdrew: Withdrawal by subject | 3 | 3 |
| Withdrew: Other | 1 | 6 |
Drug load is defined as the sum of the ratios of the actual doses divided by the defined daily dose for all concomitant AEDs.
| percent change of ratio in dose | Vimpat + Na Channel Blocking AED | Vimpat + Non-Na Channel Blocking AED |
|---|---|---|
| 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) | -15.0 ± 64.8 | -4.4 ± 31.9 |
Collected over During the entire study period (day 0 - month 6). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vimpat + Na Channel Blocking AED | — | 1/153 (0.7%) | 22/153 (14.4%) |
| Vimpat + Non-Na Channel Blocking AED | — | 6/158 (3.8%) | 9/158 (5.7%) |
| Event | Vimpat + Na Channel Blocking AED | Vimpat + Non-Na Channel Blocking AED |
|---|---|---|
| Suicidal ideationPsychiatric disorders | 1/153 | 0/158 |
| Cardiac arrestCardiac disorders | 0/153 | 1/158 |
| PalpitationsCardiac disorders | 0/153 | 1/158 |
| Electrocardiogram QT prolongedInvestigations | 0/153 | 1/158 |
| EpilepsyNervous system disorders | 0/153 | 1/158 |
| SeizureNervous system disorders | 0/153 | 1/158 |
| Adverse eventGeneral disorders | 0/153 | 1/158 |
| Confusional statePsychiatric disorders | 0/153 | 1/158 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 0/153 | 1/158 |
| Respiratory arrestRespiratory, thoracic and mediastinal disorders | 0/153 | 1/158 |
| Event | Vimpat + Na Channel Blocking AED | Vimpat + Non-Na Channel Blocking AED |
|---|---|---|
| Off label useInjury, poisoning and procedural complications | 15/153 | 7/158 |
| OverdoseInjury, poisoning and procedural complications | 15/153 | 7/158 |
| Drug ineffectiveGeneral disorders | 9/153 | 2/158 |
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.
| Age, Categorical(Participants) | Vimpat + Na Channel Blocking AED | Vimpat + Non-Na Channel Blocking AED | Total Title |
|---|---|---|---|
| <=18 years | 1 | 0 | 1 |
| Between 18 and 65 years | 135 | 117 | 252 |
| >=65 years | 17 | 41 | 58 |
| Age, Continuous(years) | Vimpat + Na Channel Blocking AED | Vimpat + Non-Na Channel Blocking AED | Total Title |
|---|---|---|---|
| Mean | 44.0 ± 16.4 | 52.5 ± 16.0 | 48.3 ± 16.7 |
| Sex: Female, Male(Participants) | Vimpat + Na Channel Blocking AED | Vimpat + Non-Na Channel Blocking AED | Total Title |
|---|---|---|---|
| Female | 79 | 66 | 145 |
| Male | 74 | 92 | 166 |
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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