Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy

Conditions: Epilepsy
MedDRA version: 17.1Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2014-004375-23-Outside-EU/EEA

Lead Sponsor: CB BIOSCIENCES, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 45

Inclusion Criteria

- Subject completed the SP0961 (2014-004379-22) study
- Subject is expected to benefit from participation in an open-label extension study with Lacosamide, in the opinion of the investigator

Are the trial subjects under 18? yes
Number of subjects for this age range: 5
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

- Subject meets the withdrawal criteria for SP0961 (2014-004379-22) or is experiencing an ongoing Serious Adverse Event (SAE)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - To obtain data on the safety and seizure frequency associated with long-term oral Lacosamide (LCM) for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects with idiopathic generalized epilepsy (IGE) <br>- To allow subjects who completed SP0961 to continue to receive LCM;Secondary Objective: Not applicable;Primary end point(s): - Number of Participants With Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (approximately 61 Weeks) <br>- Number of Participants Withdrawn From the Study Due to Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (approximately 61 Weeks) ;Timepoint(s) of evaluation of this end point: From Visit 1 to the end of study (approximately 61 weeks)

Secondary Outcome Measures