Evaluating efficacy \& safety of lacosamide versus Placebo in a blinded fashion as add-on Therapy for Primary Generalized Tonic-clonic (PGTC) seizures in subject 4 years of age or greater with idiopathic generalized epilepsy currently taking 1 to 3 antiepileptic drugs. Maximum duration of study drug administration is 28 weeks. Eligible subjects may choose to enter the open-label extension study after completion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
242
* Active Substance: Lacosamide * Pharmaceutical Form: Film-coated Tablet * Concentration: 50 mg * Route of Administration: Oral use
* Active Substance: Lacosamide * Pharmaceutical Form: Oral Solution * Concentration: 10 mg/ml * Route of Administration: Oral use
* Active Substance: Placebo * Pharmaceutical Form: Film-coated Tablet * Concentration: 50 mg * Route of Administration: Oral use
* Active Substance: Placebo * Pharmaceutical Form: Oral Solution * Concentration: 10 mg/ml * Route of Administration: Oral use
Sp0982 028
Alabaster, Alabama, United States
Sp0982 005
Little Rock, Arkansas, United States
Sp0982 018
Irvine, California, United States
Sp0982 008
Santa Monica, California, United States
Sp0982 031
Colorado Springs, Colorado, United States
Sp0982 035
Time to the Second Primary Generalized Tonic Clonic (PGTC) Seizure During the 24-week Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24)
The primary efficacy variable was the time to the second primary generalized tonic clonic seizure (PGTCS) during the 24-week Treatment Period. Relative difference between groups (Lacosamide vs Placebo) was expressed as Hazard Ratio. The indicated measured values are the observed number of events of second PGTCS in the treatment period which form the basis of the statistical analysis of the time to event analysis. The hazard ratio compares 2 treatment groups for the times to a specified number of events (125) for the combined treatment groups, and so both the number of events and the times until those events pertain to the computation of the hazard ratio. A Hazard Ratio below 1 indicates time to second PGTCS was improved for LCM compared to Placebo.
Time frame: During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)
Percentage of Participants With Seizure Freedom for Primary Generalized Tonic Clonic (PGTC) Seizures During the 24-week Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24)
A seizure-free day from primary generalized tonic clonic seizures (PGTCS) was defined as a day where no PGTCS were reported in the seizure diary and PGTCS were assessed, which was estimated using Kaplan-Meier (KM) methods.
Time frame: During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)
Time to the First Primary Generalized Tonic Clonic (PGTC) Seizure During the Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24)
The secondary efficacy variable was the time to the first primary generalized tonic clonic seizure (PGTCS) during the 24-week Treatment Period. Relative difference between groups (Lacosamide vs Placebo) was expressed as Hazard Ratio. The indicated measured values are the observed number of events of first PGTCS in the treatment period which form the basis of the statistical analysis of the time to event analysis. The hazard ratio compares 2 treatment groups for the times to the number of events for the combined treatment groups, and so both the number of events and the times until those events pertain to the computation of the hazard ratio. A Hazard Ratio below 1 indicates time to second PGTCS was improved for LCM compared to Placebo.
Time frame: During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)
Percentage of Participants With at Least One Adverse Event (AE) as Reported Spontaneously by the Subject and/or Caregiver or Observed by the Investigator
An AE was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product (IMP), whether or not related to the IMP.
Time frame: From Visit 1 (Week -4) to End of Study Period (up to Week 36)
Plasma Concentrations of Lacosamide
Lacosamide plasma concentration was expressed in micrograms per milliliter (μg/mL). Means and standard deviation (SD) were only calculated if at least 2/3 of the concentrations were quantified at the respective timepoint. Values Below Limit of Quantification (BLQ) were replaced by value of 0 in calculations of means and SDs.
Time frame: During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)
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Denver, Colorado, United States
Sp0982 036
Danbury, Connecticut, United States
Sp0982 011
Jacksonville, Florida, United States
Sp0982 013
Panama City, Florida, United States
Sp0982 002
Port Charlotte, Florida, United States
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