Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures

Phase 3CompletedNCT00520741

UCB BIOSCIENCES, Inc.426 enrolled

Overview

The objective of this historical-controlled trial is to demonstrate the efficacy and safety of conversion to Lacosamide monotherapy in subjects with Partial-onset Seizures who are withdrawn from 1 to 2 marketed antiepileptic drugs.

Sudden unexplained death in epilepsy have been reported in epilepsy patients. A causal relationship with the administration of antiepileptic drugs has not been established. The most important known risk factor for sudden unexplained death in epilepsy (SUDEP) is the occurrence and frequency of generalized tonic-clonic seizures (GTCS). Twenty-seven patients with only GTCS were enrolled in the conversion to monotherapy study. In this study, two patients with only GTCS had SUDEP. Due to the potential increased risk of SUDEP in patients with only GTCS in a trial setting, the 1 remaining patient with only GTCS was withdrawn from this study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

426

Conditions

Epilepsy

Interventions

LacosamideDRUG

50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.

LacosamideDRUG

50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.

Eligibility

Sex: ALLMin age: 16 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject has a diagnosis of Epilepsy with Simple Partial Seizures (motor component) and or Complex Partial Seizures (with or without secondary generalization) * Must be experiencing 2 to 40 seizures per 28-day period * Stable dose of 1 or 2 marketed antiepileptic drugs * Second Antiepileptic Drug (AED) must be less than or equal to 50 % of the minimum recommended maintenance dose per USA product label at screening Exclusion Criteria: * Subject has a history of primary generalized or unclassified seizures * Seizure disorder primarily characterized by isolated auras * History of status epilepticus * Seizures that are uncountable due to clustering * Has greater than 5 seizures/day * Subjects taking Benzodiazepines, Phenobarbital or Primidone * Subject has Vagus Nerve Stimulation (VNS) * Significant medical or psychiatric condition * History of alcohol or drug abuse * History of Ethosuximide use, Felbamate use after 1994 or Vigabatrin use after 1997

Locations (158)

Outcomes

Primary Outcomes

Percentage of Subjects (Using Kaplan-Meier) Who Are Identified As Meeting At Least 1 Pre-defined Exit Criteria By Day 112 Relative To The Start of Withdrawal of Background Antiepileptic Drug(s)

Pre-defined exit criteria: 1. A 2-fold or greater increase in average monthly (28-day) partial seizure frequency (motor and non-motor) compared to average monthly partial seizure frequency (motor and non-motor) during the Baseline Phase 2. A 2-fold or greater increase in consecutive 2-day partial seizure frequency (motor and non-motor) versus the highest consecutive 2-day partial seizure frequency (motor and non-motor) that occurred during the Baseline Phase. Note: if the highest consecutive 2-day partial seizure frequency during the Baseline Phase is 1, a 2-day partial seizure frequency of ≥3 is required to meet this exit criterion 3. Occurrence of a single generalized tonic-clonic seizure if none had occurred in the 6 months prior to randomization 4. A prolongation or worsening of overall seizure duration, frequency, type or pattern considered by the investigator as serious enough to warrant trial discontinuation 5. Status epilepticus, or new onset of serial/cluster seizures

Time frame: 16 Weeks Maintenance Period (approximately 112 days)

Secondary Outcomes

Time to First Occurrence of Any Exit Event During The Maintenance Period

The time to first occurrence (days) of any exit event was estimated using Kaplan-Meier methods and was based on the time from the start of the Maintenance Phase to the earliest date a subject met an exit criterion. Subjects who discontinued during the Maintenance Phase due to non-exit criteria reasons or who completed the Maintenance Phase before 112 days and did not meet an exit criterion were censored as of the last Maintenance Phase dose date. Subjects completing 112 days in the Maintenance Phase were censored as of Day 112.

Time frame: 16 Weeks Maintenance Period (approximately 112 days)

Percentage of Subjects (Using Kaplan-Meier) Who Are Identified as Meeting at Least 1 Pre-defined Exit Criteria by Day 112, Withdrew Due to Adverse Event (AE) or Withdrew Due to Lack of Efficacy During The Maintenance Period

Subjects were classified as having an exit event if they experienced at least 1 of the following events during the Maintenance Phase as of Day 112: 1. Met at least 1 exit criterion based on the calculations applied for the Primary Efficacy Analysis 2. Withdrawal due to AE with onset during the Maintenance Phase 3. Withdrew prematurely due to lack of efficacy during the Maintenance Phase The date the subject experienced the event was set to the earliest date the subject met an exit criterion or the date of the last Maintenance Phase dose for subjects not meeting an exit criterion but withdrawing due to an AE or lack of efficacy. The secondary analysis is only conducted on the Lacosamide 400 mg/day group.

Data from ClinicalTrials.gov

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