Epilepsies, Partial
Conditions
Keywords
Vimpat®, Lacosamide, LCM, epilepsy, epilepsies, seizure, partial seizure, partial onset, seizure disorder, single seizure, motor seizure, convulsions, add-on, AED, anti-epileptic, anti-epileptic drug, seizure control, open-label, post authorization, PASS, late stage, trial, study, phase 4, phase IV
Brief summary
SP942 is a non-interventional post-authorization safety study (PASS) to evaluate the long-term safety and tolerability of Vimpat® (Lacosamide, LCM) as add-on treatment in patients with Epilepsy 16 years and older with partial-onset seizures who are uncontrolled on current therapy. Using reported adverse events, the incidence of certain cardiovascular and psychiatric events will be evaluated.
Interventions
DRUGLacosamide
Vimpat was used as per site routine practices, and in-line with the marketing authorization.
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
* This study includes any subject 16 years or older who has an Epilepsy diagnosis with Partial-Onset Seizures; and whose Seizure activity is uncontrolled on current therapy * Patients who are prescribed Vimpat or any other add-on Antiepileptic Drug (AED) may be included in the study * The initiation of an add-on AED therapy can not be more than 2 days before the patient's start of the study
Exclusion criteria
* N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Incidence of Predefined Cardiovascular Treatment-Emergent Adverse Events (TEAEs) in Epilepsy Patients With Partial-onset Seizures While on Vimpat or Any Other add-on Antiepileptic Drug (AED) Treatment During the Study | From Baseline up to 12 months | Predefined cardiovascular-related Adverse Events (AEs), ie, Atrioventricular (AV) block, syncope, bradycardia, and PR prolongation, were identified as AEs coded to one of the following MedDRA Preferred Terms: Adams-Stokes syndrome, Atrioventricular block, Atrioventricular block complete, Atrioventricular block first degree, Atrioventricular block second degree, Syncope, Bradycardia, Bradyarrhythmia, Sinus bradycardia, or Electrocardiogram PR prolongation. Treatment-emergent Adverse Events (TEAEs) are those that start on or after the day of first intake of the add-on AED treatment and up to 30 days after the day of last add-on AED treatment intake. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Incidence of Predefined Psychiatric Treatment-Emergent Adverse Events (TEAEs) in Epilepsy Patients With Partial-onset Seizures While on Vimpat or Any Other add-on Antiepileptic Drug (AED) Treatment During the Study | From Baseline up to 12 months | Predefined psychiatric-related AEs, ie, depression, suicide/self-injury, drug abuse, drug dependence, substance abuse, and intentional drug misuse were predefined as AEs coded to one of the following MedDRA Preferred Terms: Depression, Major depression, Depressed mood, Depression suicidal, Completed suicide, Suicidal behavior, Suicidal ideation, Suicide attempt, Intentional self-injury, Self-injurious behavior, Self-injurious ideation, Poisoning deliberate, Drug abuse, Drug abuser, Drug dependence, Substance abuse, Substance abuser, Polysubstance dependence, Intentional drug misuse, Intentional overdose, or Multiple drug overdose intentional. Treatment-emergent Adverse Events (TEAEs) are those that start on or after the day of first intake of the add-on AED treatment and up to 30 days after the day of last add-on AED treatment intake. |
Countries
France, Germany, Netherlands, Spain, United Kingdom
Participant flow
Recruitment details
Patients were enrolled into 1 of 2 groups in this study (500 unique patients per group) at the discretion of the treating physician: patients treated with Vimpat as add-on to their current Anti-Epileptic Drug (AED) therapy (group 1) and patients treated with other approved AEDs as add-on (group 2).
Pre-assignment details
Patient procedures and assessments were performed in the frame of the current standard practice at the discretion of the treating physician. Each patient was followed for the initial 12 months of add-on AED treatment. A Safety Follow-Up Visit is recommended for any patient who terminates add-on AED treatment before the end of the study period.
Participants by arm
| Arm | Count |
|---|---|
| Lacosamide Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with add-on Vimpat | 511 |
| Other AED Epilepsy patients with partial-onset seizures who are uncontrolled on current therapy and are treated with other approved AED as add-on therapy | 493 |
| Total | 1,004 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 100 | 105 |
| Overall Study | Lack of Efficacy | 70 | 42 |
| Overall Study | Lost to Follow-up | 46 | 46 |
| Overall Study | Other reason | 23 | 27 |
| Overall Study | Withdrawal by Subject | 16 | 17 |
Baseline characteristics
| Characteristic | Lacosamide | Other AED | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 20 Participants | 14 Participants | 34 Participants |
| Age, Categorical >=65 years | 24 Participants | 45 Participants | 69 Participants |
| Age, Categorical Between 18 and 65 years | 467 Participants | 434 Participants | 901 Participants |
| Age, Continuous | 39.8 years STANDARD_DEVIATION 13.58 | 42.3 years STANDARD_DEVIATION 15.38 | 41.0 years STANDARD_DEVIATION 14.54 |
| Body Mass Index (BMI) | 26.0 kilogram per square meter STANDARD_DEVIATION 5.89 | 26.2 kilogram per square meter STANDARD_DEVIATION 5.25 | 26.1 kilogram per square meter STANDARD_DEVIATION 5.59 |
| Height | 170.4 centimeter STANDARD_DEVIATION 10.97 | 169.5 centimeter STANDARD_DEVIATION 9.24 | 170.0 centimeter STANDARD_DEVIATION 10.18 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 24 Participants | 22 Participants | 46 Participants |
| Race (NIH/OMB) White | 481 Participants | 464 Participants | 945 Participants |
| Sex: Female, Male Female | 266 Participants | 282 Participants | 548 Participants |
| Sex: Female, Male Male | 245 Participants | 211 Participants | 456 Participants |
| Weight | 75.5 kilogram STANDARD_DEVIATION 18.1 | 75.7 kilogram STANDARD_DEVIATION 17.68 | 75.6 kilogram STANDARD_DEVIATION 17.89 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 359 / 511 | 299 / 493 |
| serious Total, serious adverse events | 78 / 511 | 64 / 493 |
Outcome results
Primary
The Incidence of Predefined Cardiovascular Treatment-Emergent Adverse Events (TEAEs) in Epilepsy Patients With Partial-onset Seizures While on Vimpat or Any Other add-on Antiepileptic Drug (AED) Treatment During the Study
Predefined cardiovascular-related Adverse Events (AEs), ie, Atrioventricular (AV) block, syncope, bradycardia, and PR prolongation, were identified as AEs coded to one of the following MedDRA Preferred Terms: Adams-Stokes syndrome, Atrioventricular block, Atrioventricular block complete, Atrioventricular block first degree, Atrioventricular block second degree, Syncope, Bradycardia, Bradyarrhythmia, Sinus bradycardia, or Electrocardiogram PR prolongation. Treatment-emergent Adverse Events (TEAEs) are those that start on or after the day of first intake of the add-on AED treatment and up to 30 days after the day of last add-on AED treatment intake.
Time frame: From Baseline up to 12 months
Population: Safety Set (SS) population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lacosamide | The Incidence of Predefined Cardiovascular Treatment-Emergent Adverse Events (TEAEs) in Epilepsy Patients With Partial-onset Seizures While on Vimpat or Any Other add-on Antiepileptic Drug (AED) Treatment During the Study | 4 Treatment-Emergent Adverse Events |
| Other AED | The Incidence of Predefined Cardiovascular Treatment-Emergent Adverse Events (TEAEs) in Epilepsy Patients With Partial-onset Seizures While on Vimpat or Any Other add-on Antiepileptic Drug (AED) Treatment During the Study | 3 Treatment-Emergent Adverse Events |
Secondary
The Incidence of Predefined Psychiatric Treatment-Emergent Adverse Events (TEAEs) in Epilepsy Patients With Partial-onset Seizures While on Vimpat or Any Other add-on Antiepileptic Drug (AED) Treatment During the Study
Predefined psychiatric-related AEs, ie, depression, suicide/self-injury, drug abuse, drug dependence, substance abuse, and intentional drug misuse were predefined as AEs coded to one of the following MedDRA Preferred Terms: Depression, Major depression, Depressed mood, Depression suicidal, Completed suicide, Suicidal behavior, Suicidal ideation, Suicide attempt, Intentional self-injury, Self-injurious behavior, Self-injurious ideation, Poisoning deliberate, Drug abuse, Drug abuser, Drug dependence, Substance abuse, Substance abuser, Polysubstance dependence, Intentional drug misuse, Intentional overdose, or Multiple drug overdose intentional. Treatment-emergent Adverse Events (TEAEs) are those that start on or after the day of first intake of the add-on AED treatment and up to 30 days after the day of last add-on AED treatment intake.
Time frame: From Baseline up to 12 months
Population: Safety Set (SS) population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lacosamide | The Incidence of Predefined Psychiatric Treatment-Emergent Adverse Events (TEAEs) in Epilepsy Patients With Partial-onset Seizures While on Vimpat or Any Other add-on Antiepileptic Drug (AED) Treatment During the Study | 22 Treatment-Emergent Adverse Events |
| Other AED | The Incidence of Predefined Psychiatric Treatment-Emergent Adverse Events (TEAEs) in Epilepsy Patients With Partial-onset Seizures While on Vimpat or Any Other add-on Antiepileptic Drug (AED) Treatment During the Study | 31 Treatment-Emergent Adverse Events |