Safety and Efficacy of Lacosamide as Additional Therapy in Patients Suffering From Epileptic Tonic-Clonic Seizures

Purpose

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.

Condition

  • Epilepsy

Eligibility

Eligible Ages
Over 4 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Lacosamide 		Start dose SP0982 completers at V1: LCM 10 mg/kg/day for pediatric subjects weighing <30 kg LCM 8 mg/kg/day for pediatric subjects weighing ≥ 30kg to <50 kg LCM 400 mg/day (200 mg bid) for adult subjects (≥18 years of age) or pediatric subjects weighing ≥50 kg SP0982 Baseline failures at V1: LCM 2 mg/kg/day for pediatric subjects weighing <50 kg LCM 100 mg/day (50 mg bid) for adult subjects (≥18 years of age) or pediatric subjects weighing ≥50 kg Oral solution (pediatric subjects <50 kg): Minimum LCM dose: 4 mg/kg/day Maximum LCM dose: 12 mg/kg/day Tablets (pediatric subjects ≥50kg): Minimum LCM dose: 200 mg/day Minimum LCM dose: 600 mg/day Tablets (adult subjects): Minimum LCM dose: 200 mg/day Maximum LCM dose: 800 mg/day
  • Drug: Lacosamide Tablet
    Active substance: Lacosamide Pharmaceutical form: Tablet Concentration: 50 mg and 100 mg Route of Administration: Oral administration
    Other names:
    • Vimpat
    • LCM
  • Drug: Lacosamide Oral Solution
    Active substance: Lacosamide Pharmaceutical form: Oral solution Concentration: 10 mg/ml Route of Administration: Oral administration
    Other names:
    • Vimpat
    • LCM

More Details

Status
Completed
Sponsor
UCB BIOSCIENCES, Inc.

Study Contact