Epilepsy
Conditions
Keywords
Epilepsy, Partial-onset Seizures, Lacosamide, Monotherapy, Vimpat
Brief summary
This open-label extension trial will assess the long-term use of Lacosamide monotherapy and safety of Lacosamide monotherapy and adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the conversion to monotherapy trial (SP902).
Interventions
DRUGLacosamide
50 mg and 100 mg Lacosamide tablets taken for 50 -400 mg twice daily dosing for up to 2 years
Sponsors
UCB Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Subject has entered the Maintenance Phase of the double-blind trial, SP902, (ie, has taken at least 1 dose of SP902 Maintenance Phase trial medication) and either completed SP902 or met an exit criterion in SP902; subject is allowed up to 2 concomitant Antiepileptic Drugs (AEDs)
Exclusion criteria
* Subject meets the withdrawal criteria (excluding exit criteria) for the SP902 trial, or is experiencing an ongoing Serious Adverse Event (SAE)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects on Lacosamide (LCM) Monotherapy at Any Time Between Visit 1 and End of Study | From Visit 1 to End of Study (approximately 2 years) | Percentage of Subjects on Lacosamide (LCM) Monotherapy at any time between Visit 1 and End of Study. |
| Duration of Lacosamide (LCM) Monotherapy Treatment From Visit 1 to End of Study | From Visit 1 to End of Study (approximately 2 years) | Duration of total Lacosamide Monotherapy From Visit 1 to End of Study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of At Least One Treatment-Emergent Adverse Event (TEAE) From Visit 1 to End of Study | From Visit 1 to End of Study (approximately 2 years) | A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases. An TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design). |
| Occurrence of Treatment-Emergent Adverse Events (TEAE) Leading to Subject Withdrawal From Visit 1 to End of Study | From Visit 1 to End of Study (approximately 2 years) | — |
Countries
Australia, Canada, Denmark, Germany, Italy, Poland, Spain, United Kingdom, United States
Participant flow
Recruitment details
This Multicenter, Open-Label Study started to enroll Subjects in February 2008.
Pre-assignment details
Participant Flow refers to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
Participants by arm
| Arm | Count |
|---|---|
| Lacosamide Lacosamide tablets for dosing 100 -800 mg/day | 322 |
| Total | 322 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Fatal Serious AE | 3 |
| Overall Study | Lack of Efficacy | 20 |
| Overall Study | Lost to Follow-up | 9 |
| Overall Study | Non Fatal Non Serious AE | 12 |
| Overall Study | Non Fatal Serious AE | 7 |
| Overall Study | Other reason for premature termination | 17 |
| Overall Study | Protocol Violation | 3 |
| Overall Study | Unsatisfactory compliance of subject | 11 |
| Overall Study | Withdrawal by Subject | 30 |
Baseline characteristics
| Characteristic | Lacosamide |
|---|---|
| Age, Categorical <=18 years | 8 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 301 Participants |
| Age, Continuous mean (standard deviation) | 40.7 years STANDARD_DEVIATION 13.3 |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 46 Participants |
| Race/Ethnicity, Customized Other | 17 Participants |
| Race/Ethnicity, Customized White | 258 Participants |
| Sex: Female, Male Female | 161 Participants |
| Sex: Female, Male Male | 161 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 238 / 322 |
| serious Total, serious adverse events | 56 / 322 |
Outcome results
Primary
Duration of Lacosamide (LCM) Monotherapy Treatment From Visit 1 to End of Study
Duration of total Lacosamide Monotherapy From Visit 1 to End of Study.
Time frame: From Visit 1 to End of Study (approximately 2 years)
Population: All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lacosamide | Duration of Lacosamide (LCM) Monotherapy Treatment From Visit 1 to End of Study | 479.1 days | Standard Deviation 271.9 |
Primary
Percentage of Subjects on Lacosamide (LCM) Monotherapy at Any Time Between Visit 1 and End of Study
Percentage of Subjects on Lacosamide (LCM) Monotherapy at any time between Visit 1 and End of Study.
Time frame: From Visit 1 to End of Study (approximately 2 years)
Population: All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lacosamide | Percentage of Subjects on Lacosamide (LCM) Monotherapy at Any Time Between Visit 1 and End of Study | 292 Participants |
Secondary
Occurrence of At Least One Treatment-Emergent Adverse Event (TEAE) From Visit 1 to End of Study
A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases. An TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design).
Time frame: From Visit 1 to End of Study (approximately 2 years)
Population: All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lacosamide | Occurrence of At Least One Treatment-Emergent Adverse Event (TEAE) From Visit 1 to End of Study | 296 Participants |
Secondary
Occurrence of Treatment-Emergent Adverse Events (TEAE) Leading to Subject Withdrawal From Visit 1 to End of Study
Time frame: From Visit 1 to End of Study (approximately 2 years)
Population: All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lacosamide | Occurrence of Treatment-Emergent Adverse Events (TEAE) Leading to Subject Withdrawal From Visit 1 to End of Study | 22 Participants |