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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.