A Study to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial Onset Seizures
- Conditions
- Partial Onset SeizuresTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2014-003622-41-Outside-EU/EEA
- Lead Sponsor
- CB Pharma SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 676
- Subject has had an Electroencephalogram (EEG) and a brain Computerized Tomography (CT) scan or Magnetic Resonance Imaging (MRI) exam consistent with a Diagnosis of Epilepsy with Partial-Onset Seizures according to the International Classification of Epileptic Seizures (1981)
- Subject must have been observed to have Partial-Onset Seizures for at least the previous 2 years despite prior therapy with at least 2 Anti-Epileptic Drugs (AEDs)(concurrently or sequentially) and must have been observed to have on average at least 4 Partial-Onset Seizures per 28 days with a seizure-free phase no longer than 21 days in the 8-Week Period prior to entry into the Baseline Period. In the case of Simple Partial Seizures, only those with motor signs will be counted towards meeting the inclusion criterion
- Subjects must be on a stable dose regimen of at least 1, but no more than 3 AEDs (concurrent stable Vagus Nerve Stimulation (VNS) is not counted as an AED). The VNS must have been in place for at least 6 months prior to study entry. The dosage of concomitant AED therapy and the settings of the VNS must be kept constant for a period of at least 4 weeks prior to entry into the Baseline Period
- Minimum Body Weight of 40 kg
Are the trial subjects under 18? yes
Number of subjects for this age range: 44
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 627
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
- Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt) or has a suicidal ideation in the past 6 months as indicated by a positive response (Yes) to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening
- Subject has a current or previous diagnosis of Pseudo-Seizures, Conversion Disorders, or other non-epileptical events that could be confused with Seizures
- Subject has Seizures that are uncountable due to Clustering (ie, an episode lasting less than 30 minutes in which several Seizures occur with such frequency that the initiation and completion of each individual Seizure cannot be distinguished) during the 8-Week Period prior to Visit 1
- Subject has a history of Primary Generalized Seizures
- Subject with a history of Status Epilepticus within the 12-Months Period prior to Visit 1
- Subject who underwent surgery for Epilepsy within the 2 Years Period prior to Visit 1
- Subjects with cardiac, renal, hepatic, endocrinological dysfunction or psychiatric illness that may impair reliable participation in the study or necessitate the use of medication not allowed by the protocol
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 of this study is to evaluate the efficacy of Lacosamide (LCM) administered concomitantly with 1 to 3 Anti-epileptic Drugs (AED(s)) in Japanese and Chinese subjects with or without additional VNS who currently have uncontrolled partial-onset seizures with or without secondary generalization.<br>;Secondary Objective: The secondary objectives are to evaluate the safety and tolerability of LCM, the dose response relationships of the efficacy and safety of LCM, and the steady state plasma concentrations of LCM.;Primary end point(s): Change in Partial-Onset Seizure frequency per 28 days from Baseline to the Maintenance Period;Timepoint(s) of evaluation of this end point: From start of the 8-Week Baseline Period (Visit 1 to Visit 3) to the end of the 16-Week Treatment Period (Visit 3 to Visit 8)
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: - From start of the 8-Week Baseline Period (Visit 1 to Visit 3) to the end of the 12-Week Maintenance Period (Visit 5 to Visit 8)<br>- From start of the 8-Week Baseline Period (Visit 1 to Visit 3) to the end of the 16-Week Treatment Period (Visit 3 to Visit 8)<br>;Secondary end point(s): The portion of individual patients who experience a 50 % or greater reduction in Partial-Onset Seizure frequency from Baseline to the Maintenance Period (50 % responder rate)<br>- Percent change in Partial-Onset Seizure frequency per 28 days from Baseline to the Maintenance Period<br>- Change in Partial-Onset Seizure frequency per 28 days from Baseline to the Treatment Period (ie, Titration + Maintenance Period)<br>