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

UCB

Status and phase: Completed; Phase 3

Conditions: Epilepsy

Treatments: Drug: Lacosamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00520741

SP0902

2007-005439-27 (EudraCT Number)

Details and patient eligibility

About

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the efficacy and safety of conversion to Lacosamide monotherapy in subjects with Partial-onset Seizures who are withdrawn from 1 to 2 marketed antiepileptic drugs.

Full description

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increased risk of SUDEP in patients with only GTCS in a trial setting, the 1 remaining patient with only GTCS was withdrawn from this study.

Enrollment: 426 patients

Sex: All

Ages: 16 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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426 participants in 2 patient groups

Lacosamide 400 mg/day

Experimental group

Description:

Lacosamide 400 mg/day

Treatment:

Drug: Lacosamide

Drug: Lacosamide

Lacosamide 300 mg/day

Active Comparator group

Description:

Lacosamide 300 mg/day

Treatment:

Drug: Lacosamide

Drug: Lacosamide