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

Phase 3

Completed

Conditions: Epilepsy

Interventions: Drug: Lacosamide

Registration Number: NCT02582866

Lead Sponsor: UCB Biopharma S.P.R.L.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 106

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lacosamide	Lacosamide	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.

Primary Outcome Measures

Name	Time	Method
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.
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 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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (46): Sp1042 805
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Blagoevgrad, Bulgaria
Sp1042 807
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Pazardzhik, Bulgaria
Sp1042 811
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Sofia, Bulgaria
Sp1042 205
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Helsinki, Finland
Sp1042 207
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Kuopio, Finland
Sp1042 236
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Nancy, France
Sp1042 263
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Altenburg, Germany
Sp1042 265
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Bad Neustadt An Der Saale, Germany
Sp1042 269
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Leipzig, Germany
Sp1042 256
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Marburg, Germany
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Sp1042 805
🇧🇬Blagoevgrad, Bulgaria