Epilepsy, Partial-onset Seizures
Conditions
Keywords
Lacosamide, Epilepsy, Partial-onset Seizures
Brief summary
The purpose of this trial is to evaluate the safety and tolerability of long-term administration of Lacosamide at doses up to 400 mg/day in Japanese and Chinese adults with Epilepsy who have completed the Treatment and Transition Period of EP0008 \[NCT01710657\]
Interventions
DRUGLacosamide
Strength: Lacosamide (LCM) 50 mg, LCM 100 mg Formulation: Tablet Frequency: twice daily during the study period (until the date of approval) At the completion of EP0008 \[NCT01710657\], all subjects who choose to enroll in EP0009 will be taking a dose of Lacosamide 200 mg/day. At the beginning of EP0009, the investigator may maintain the LCM dose or increase or decrease the dose. During the Treatment Period, the investigator will be allowed to increase or decrease the dose of LCM to optimize tolerability and seizure reduction. The LCM dose may be decreased to 100 mg/day or increased, no faster than 100 mg/day per week, up to 400 mg/day.
Sponsors
UCB Japan Co. Ltd.
UCB Pharma SA
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 completed the Treatment and Transition Period of EP0008 \[NCT01710657\]
Exclusion criteria
* Subjects who withdrew from EP0008 \[NCT01710657\]
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With at Least One Adverse Event Reported Spontaneously by the Subject or Observed by the Investigator From Baseline Until the End of Study Visit | From Visit 1 (Week 0) up to approximately Week 323 | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. |
| Number of Participants That Withdrew Due to Adverse Events From Baseline Until the End of Study Visit | From Visit 1 (Week 0) up to approximately Week 323 | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment and led to the withdrawal of the participants from the study. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Partial-onset Seizure Frequency Per 28 Days From Baseline of Study EP0008 [NCT01710657] Until the End of Study Visit in Study EP0009 | From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 323 in study EP0009 | The percent change from Baseline to the Treatment Period was calculated as {\[(Seizure frequency per 28 days during the Treatment Period) minus (Seizure frequency per 28 days during Baseline Period)\] divided by (Seizure frequency per 28 days during Baseline Period)} multiplied by 100. Baseline was defined as the Baseline Period of study EP0008 \[NCT01710657\]. |
| Percentage of Participants With 50 % Response Rate in Partial-onset Seizure Frequency Per 28 Days From Baseline of Study EP0008 [NCT01710657] Until the End of Study Visit in Study EP0009 | From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 323 in study EP0009 | A responder is a subject experiencing a greater than or equal to (≥) 50 % reduction in partial-onset seizure frequency per 28 days from baseline. Baseline was defined as the Baseline Period of study EP0008 \[NCT01710657\]. |
Countries
China, Japan
Participant flow
Recruitment details
The study started to enroll participants in March 2013 and concluded in July 2019.
Pre-assignment details
Participant Flow refers to the Safety Set.
Participants by arm
| Arm | Count |
|---|---|
| Lacosamide At the completion of EP0008 \[NCT01710657\], all participants who enrolled in EP0009 were administered a dose of 200 mg/day lacosamide (LCM). The LCM dose may have been decreased to 100 mg/day or increased, no faster than 100 mg/day per week, up to 400 mg/day, at the investigator's discretion. | 473 |
| Total | 473 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 50 |
| Overall Study | Back home | 1 |
| Overall Study | Bad mood and has suicidal thought | 1 |
| Overall Study | Changes of implementation system | 3 |
| Overall Study | Death | 5 |
| Overall Study | Lack of Efficacy | 81 |
| Overall Study | Lost to Follow-up | 10 |
| Overall Study | Low compliance | 3 |
| Overall Study | Not convenient to come back to site | 2 |
| Overall Study | Not possible to visit the hospital | 1 |
| Overall Study | Participant was asked to quit | 5 |
| Overall Study | Plan to pregnancy | 7 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Pregnancy and abortion in EP0008 study | 1 |
| Overall Study | Prohibited concomitant medication | 1 |
| Overall Study | Prohibit procedure | 2 |
| Overall Study | Protocol Violation | 7 |
| Overall Study | Subject considered the efficacy was poor | 1 |
| Overall Study | Subject refused to return visit | 2 |
| Overall Study | Visit non-compliance | 2 |
| Overall Study | Withdrawal by Subject | 49 |
Baseline characteristics
| Characteristic | Lacosamide |
|---|---|
| Age, Categorical <=18 years | 39 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 432 Participants |
| Age, Continuous | 32.7 years STANDARD_DEVIATION 12 |
| Race/Ethnicity, Customized Chinese | 350 Participants |
| Race/Ethnicity, Customized Japanese | 123 Participants |
| Sex/Gender, Customized Female | 214 Participants |
| Sex/Gender, Customized Male | 259 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 473 |
| other Total, other adverse events | 343 / 473 |
| serious Total, serious adverse events | 83 / 473 |
Outcome results
Primary
Number of Participants That Withdrew Due to Adverse Events From Baseline Until the End of Study Visit
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment and led to the withdrawal of the participants from the study. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time frame: From Visit 1 (Week 0) up to approximately Week 323
Population: The Safety Set (SS) included all enrolled participants in EP0009 who took at least 1 dose of LCM in EP0009.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lacosamide (SS) | Number of Participants That Withdrew Due to Adverse Events From Baseline Until the End of Study Visit | 51 Participants |
Primary
Number of Participants With at Least One Adverse Event Reported Spontaneously by the Subject or Observed by the Investigator From Baseline Until the End of Study Visit
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time frame: From Visit 1 (Week 0) up to approximately Week 323
Population: The Safety Set (SS) included all enrolled participants in EP0009 who took at least 1 dose of LCM in EP0009.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lacosamide (SS) | Number of Participants With at Least One Adverse Event Reported Spontaneously by the Subject or Observed by the Investigator From Baseline Until the End of Study Visit | 410 Participants |
Secondary
Percentage of Participants With 50 % Response Rate in Partial-onset Seizure Frequency Per 28 Days From Baseline of Study EP0008 [NCT01710657] Until the End of Study Visit in Study EP0009
A responder is a subject experiencing a greater than or equal to (≥) 50 % reduction in partial-onset seizure frequency per 28 days from baseline. Baseline was defined as the Baseline Period of study EP0008 \[NCT01710657\].
Time frame: From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 323 in study EP0009
Population: The Full Analysis Set (FAS) included all study participants from the SS who had at least 1 day with available seizure diary data in study EP0009.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lacosamide (SS) | Percentage of Participants With 50 % Response Rate in Partial-onset Seizure Frequency Per 28 Days From Baseline of Study EP0008 [NCT01710657] Until the End of Study Visit in Study EP0009 | 57.1 percentage of participants |
Secondary
Percent Change in Partial-onset Seizure Frequency Per 28 Days From Baseline of Study EP0008 [NCT01710657] Until the End of Study Visit in Study EP0009
The percent change from Baseline to the Treatment Period was calculated as {\[(Seizure frequency per 28 days during the Treatment Period) minus (Seizure frequency per 28 days during Baseline Period)\] divided by (Seizure frequency per 28 days during Baseline Period)} multiplied by 100. Baseline was defined as the Baseline Period of study EP0008 \[NCT01710657\].
Time frame: From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 323 in study EP0009
Population: The Full Analysis Set (FAS) included all study participants from the SS who had at least 1 day with available seizure diary data in study EP0009.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lacosamide (SS) | Percent Change in Partial-onset Seizure Frequency Per 28 Days From Baseline of Study EP0008 [NCT01710657] Until the End of Study Visit in Study EP0009 | -44.47 Percent change | Standard Deviation 55.82 |