SAFETY AND EFFICACY OF LACOSMIDE AS ADDITIONAL THERAPY IN PATIENTS SUFFERING FROM EPILEPTIC TONIC CLONIC SEIZURES

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent/Assent Form for the open-label extension study (EP0012) must be 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 must have completed or be an eligible Baseline failure from the parent study (SP0982), as defined in protocol Section 5.1.

3. Subject/legally acceptable representative considered as reliable and capable of adhering to the protocol (eg, able to understand and complete diaries and questionnaires), visit schedule and medication intake according to the judgment of the investigator.
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. Subject is receiving any investigational drugs or using any experimental devices in addition to LCM.

2. Subject meets the withdrawal criteria for SP0982 or is experiencing an ongoing serious adverse event (SAE).

3. Subject has an active suicidal ideation as indicated by a positive response (Yes”) to either Question 4 or Question 5 of the Since Last Visit” version of the Columbia-Suicide Severity Rating Scale (C-SSRS). The subject should be referred immediately to a Mental Healthcare Professional.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to assess the safety and tolerability of LCM as an adjunctive therapy for uncontrolled PGTC seizures in subjects with IGE during long-term exposure.;Secondary Objective: The secondary objectives are:<br>- To assess the efficacy of adjunctive LCM therapy during long-term exposure for the treatment of subjects with IGE experiencing uncontrolled PGTC seizures<br>- To allow subjects who have completed SP0982 and eligible Baseline failures from SP0982 to receive LCM;Primary end point(s): Adverse events as reported spontaneously by the subject and/or caregiver or observed by the investigator<br><br>Subject withdrawals due to AEs;Timepoint(s) of evaluation of this end point: Up to 5 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Changes in hematology, chemistry, and urinalysis parameters<br><br>Changes in 12-lead ECGs<br><br>Changes in vital sign measurements (ie, BP and pulse rate), including body weight and physical (including neurological) examination findings<br>;Timepoint(s) of evaluation of this end point: Up to 5 years

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