Epilepsy
Conditions
Keywords
Lacosamide, Vimpat, Epilepsy, Partial onset seizures, Tonic-clonic seizures, Monotherapy, AED
Brief summary
Study is conducted to evaluate the long-term safety and tolerability of lacosamide (LCM) in patients receiving LCM in SP0994 \[NCT01465997\]. The study will enable collection of additional monotherapy safety data, and will facilitate access to treatment until commercial availability for monotherapy use.
Interventions
DRUGLacosamide
* Pharmaceutical Form: Oral tablets * Concentration: 50 mg * Route of Administration: Oral administration
Sponsors
Parexel
UCB Biopharma S.P.R.L.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* An Institutional Review Board /Institutional Ethics Committee approved written Informed Consent Form (ICF) is signed and dated by the subject or by the parent(s) or legal representative. The ICF or a specific Assent form, where required, will be signed and dated by minors * Subject/legal representative is considered reliable and capable of adhering to the protocol, visit schedule, and medication intake according to the judgment of the investigator * Subject has completed the Termination Visit of SP0994 \[NCT01465997\] and has been treated with lacosamide monotherapy
Exclusion criteria
* Subject is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM) * Subject experienced a seizure at the 3rd target dose (i.e. LCM 600 mg/day) during SP0994 * Subject required another Anti Epileptic Drug (AED) for the treatment of seizures * Subject meets a must withdrawal criteria for SP0994 * Subject is experiencing an ongoing Serious Adverse Event from SP0994 * Female subject who is pregnant or nursing, and/or a woman of childbearing potential who is not surgically sterile, 2 year postmenopausal or does not practice one highly effective method of contraception, unless sexually abstinent, for the duration of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Experiencing Any Adverse Events (AEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator | From Visit 1 (Week 0) to Final Visit (up to Week 158) | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication. |
| Percentage of Participants That Withdrew Due to Adverse Events (AEs) | From Visit 1 (Week 0) to Final Visit (up to Week 158) | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication. |
| Percentage of Participants Experiencing Any Serious Adverse Events (SAEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator | From Visit 1 (Week 0) to Final Visit (up to Week 158) | A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalization or prolongation of existing hospitalization * Is a congenital anomaly or birth defect * Is an infection that requires treatment parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardize the study participants, or may require medical or surgical intervention to prevent any of the above. |
Countries
Bulgaria, Finland, France, Germany, Japan, Latvia, Mexico, Philippines, Poland, Romania, Russia, South Korea, Sweden, Switzerland, Ukraine
Participant flow
Recruitment details
The study started to enroll study participants in January 2016 and concluded in January 2020.
Pre-assignment details
Participant Flow refers to the Safety Set.
Participants by arm
| Arm | Count |
|---|---|
| Lacosamide Lacosamide (LCM) was administered orally, twice daily from 200 mg/day to 600 mg/day, in 2 divided doses at approximately 12 hour intervals in the morning and in the evening. The investigator may have maintained the subject's LCM dose, decreased the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increased the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day.
Participants stopping LCM should have been tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper was permitted but the duration of tapering should not have exceeded 6 weeks. | 106 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Investigator decision | 5 |
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Participant wants to get pregnant | 1 |
| Overall Study | Pregnancy | 2 |
| Overall Study | Sponsor decision | 1 |
| Overall Study | Withdrawal by Subject | 7 |
| Overall Study | Withdrawal due to personal reasons | 1 |
Baseline characteristics
| Characteristic | Lacosamide |
|---|---|
| Age, Categorical <=18 years | 2 Participants |
| Age, Categorical >=65 years | 14 Participants |
| Age, Categorical Between 18 and 65 years | 90 Participants |
| Age, Continuous | 43.5 years STANDARD_DEVIATION 17.1 |
| Race/Ethnicity, Customized Asian | 19 Participants |
| Race/Ethnicity, Customized Other/Mixed | 1 Participants |
| Race/Ethnicity, Customized White | 86 Participants |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 106 |
| other Total, other adverse events | 19 / 106 |
| serious Total, serious adverse events | 15 / 106 |
Outcome results
Primary
Percentage of Participants Experiencing Any Adverse Events (AEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication.
Time frame: From Visit 1 (Week 0) to Final Visit (up to Week 158)
Population: The SS consisted of all study participants in the ES who received at least 1 dose of study medication in SP1042.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lacosamide (SS) | Percentage of Participants Experiencing Any Adverse Events (AEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator | 59.4 percentage of participants |
Primary
Percentage of Participants Experiencing Any Serious Adverse Events (SAEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalization or prolongation of existing hospitalization * Is a congenital anomaly or birth defect * Is an infection that requires treatment parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardize the study participants, or may require medical or surgical intervention to prevent any of the above.
Time frame: From Visit 1 (Week 0) to Final Visit (up to Week 158)
Population: The SS consisted of all study participants in the ES who received at least 1 dose of study medication in SP1042.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lacosamide (SS) | Percentage of Participants Experiencing Any Serious Adverse Events (SAEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator | 14.2 percentage of participants |
Primary
Percentage of Participants That Withdrew Due to Adverse Events (AEs)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication.
Time frame: From Visit 1 (Week 0) to Final Visit (up to Week 158)
Population: The SS consisted of all study participants in the ES who received at least 1 dose of study medication in SP1042.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lacosamide (SS) | Percentage of Participants That Withdrew Due to Adverse Events (AEs) | 0.9 percentage of participants |