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

UCB

Status and phase: Completed; Phase 3

Conditions: Epilepsy

Treatments: Drug: Lacosamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02582866

2015-001549-96 (EudraCT Number)

SP1042

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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106 participants in 1 patient group

Lacosamide

Experimental group

Description:

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.

Treatment:

Drug: Lacosamide