A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Open-label, Follow-up Study to Assess the Long-term Use of Lacosamide (Flexible Dose From 200 to 600 mg/Day) Used as Monotherapy in Subjects Who Completed SP0994 and Received Lacosamide Monotherapy Treatment

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: Lacosamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lacosamide<br>Lacosamide (LCM) will be administered orally twice daily from 200 mg/day to 600 mg/day (at approximately 12 hour intervals in the morning and in the evening) in 2 divided doses. Medication must not be chewed and must be swallowed with a sufficient amount of fluid. The investigator may maintain the subject's LCM dose, decrease the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increase the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day. Subjects stopping LCM should be tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper is permitted, if medically necessary; however, the maximum duration of tapering should not exceed 6 weeks. | Drug: Lacosamide<br>* Pharmaceutical Form: Oral tablets Concentration: 50 mg Route of Administration: Oral administration<br>* Other names: LCM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From Visit 1 (Week 0) to Final Visit (up to Week 158) | 
| 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. | From Visit 1 (Week 0) to Final Visit (up to Week 158) | 
| 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. | From Visit 1 (Week 0) to Final Visit (up to Week 158) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AED, Lacosamide, Vimpat, Epilepsy, Partial onset seizures, Tonic-clonic seizures, Monotherapy