Safety and Efficacy of Lacosamide as Additional Therapy in Patients Suffering From Epileptic Tonic-Clonic Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Intervention: Lacosamide Tablet; Lacosamide Oral Solution
Intervention description: Active substance: Lacosamide
Pharmaceutical form: Tablet
Concentration: 50 mg and 100 mg
Route of Administration: Oral administration; Active substance: Lacosamide
Pharmaceutical form: Oral solution
Concentration: 10 mg/ml
Route of Administration: Oral administration
Intervention MeSH terms: Lacosamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 239.0
Sex: All
Minimum age: 4 Years
Healthy volunteers: No
Keywords: Lacosamide; Vimpat; Epilepsy; Children; Primary Generalized Tonic Clonic seizures; Idiopathic Generalized Epilepsy; Adults

Summary:

      Assessment of long-term safety and efficacy of oral lacosamide (LCM) as an adjunctive therapy
      for uncontrolled primary generalized tonic-clonic seizures (PGTCS) in subjects >= 4 years of
      age with idiopathic generalized epilepsy (IGE). This study will enroll subjects from the LCM
      SP0982 [NCT02408523] study.
    

Eligibility criteria:

        Inclusion Criteria:

        - Subject must have completed or be an eligible Baseline failure from the parent study
        (SP0982 [NCT02408523]). Note: Other subjects screened for SP0982 may be considered for
        roll-over to EP0012 if the investigator considers that the subject could benefit from
        treatment with open-label lacosamide (LCM) and based on prior discussion with and approval
        from the UCB Study Physician or representative

        Exclusion Criteria:

          -  Subject is receiving any investigational drugs or using any experimental devices in
             addition to lacosamide (LCM)

          -  Subject meets the withdrawal criteria for SP0982 or is experiencing an ongoing serious
             adverse event (SAE)

          -  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)

          -  Subject has >=2x upper limit of normal (ULN) of any of the following: alanine
             aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP),
             or >ULN total bilirubin (≥1.5xULN total bilirubin if known Gilbert's syndrome). If
             subject has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate
             bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin
             <35%). For all subjects who entered EP0012 directly with a Baseline result >ULN for
             ALT, AST, ALP, or total bilirubin, a Baseline diagnosis and/or the cause of any
             clinically meaningful elevation must be understood and recorded in the electronic Case
             Report form (eCRF). Tests that result in ALT, AST, or ALP up to 25% above the
             exclusion limit may be repeated once for confirmation.