A multicenter, openlabel, follow-up study to assess the longterm use of Lacosamide (flexible dose from 200 to 600 mg/day) used as monotherapy in subjects who completed SP0994 and received Lacosamide monotherapy treatment

PHRR160125-001158

SP1042

2015-CT0315

A multicenter, openlabel, follow-up study to assess the longterm use of Lacosamide (flexible dose from 200 to 600 mg/day) used as monotherapy in subjects who completed SP0994 and received Lacosamide monotherapy treatment

a long-term, open-label, follow-up study for subjects being treated with Lacosamide monotherapy at the time of unblinding of SP0994

Completed

partial-onset seizures or generalized tonic-clonic seizures

long-term safety and tolerability of Lacosamide dosed at 200mg/day to 600mg/day (Adverse Events reported)

Unspecified

Completed

• Bulgaria
• Finland
• France
• Germany
• Japan
• Latvia
• Mexico
• Poland
• Russia
• South Korea
• Sweden
• Switzerland
• Ukraine

Clinical Trial

20150904113046

2016-01-05

0000-00-00

16

4

Unspecified

2016-11-22

Inclusion criteria
To be eligible to participate in this study, all of the following criteria must be met:
1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject or by the parent(s) or legal representative. The Informed Consent form or a specific Assent form, where required, will be signed and dated by minors.
2. 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.
3. Subject has completed the Termination Visit of SP0994 and has been treated with LCM monotherapy.

Exclusion criteria
Subjects are not permitted to enroll in the study if any of the following criteria are met:
1. Subject is receiving any investigational drugs or using any experimental devices in addition to LCM.
2. Subject experienced a seizure at the third target dose (ie, LCM 600 mg/day) during SP0994.
3. Subject requires another AED for the treatment of seizures.
4. Subject meets a “must” withdrawal criterion for the previous study, SP0994.
5. Subject is experiencing an ongoing SAE from the previous study, SP0994.
6. 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 (according to ICH guidance defined as those that result in a failure rate of less than 1% per year when used consistently and correctly), unless sexually abstinent, for the duration of the study.

Interventional

Lacosamide

Subject numbers were assigned at the beginning of SP0993 and will remain the same in SP1042.

Randomized

Open Label

Unspecified

Parallel

assess the long-term safety and tolerability of LCM dosed at  200mg/day to 600mg/day when used as monotherapy in subjects, with partial-onset seizures or generalized tonic-clonic seizures (without clear focal origin), who completed SP0994 and received LCM

Phase III