Trial to Assess Long-term Lacosamide (LCM) Monotherapy Use and Safety of LCM Monotherapy and Adjunctive Therapy for Partial-onset Seizures

UCB Pharma322 enrolled

Overview

This open-label extension trial will assess the long-term use of Lacosamide monotherapy and safety of Lacosamide monotherapy and adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the conversion to monotherapy trial (SP902).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

322

Conditions

Epilepsy

Interventions

LacosamideDRUG

50 mg and 100 mg Lacosamide tablets taken for 50 -400 mg twice daily dosing for up to 2 years

Eligibility

Sex: ALLMin age: 16 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject has entered the Maintenance Phase of the double-blind trial, SP902, (ie, has taken at least 1 dose of SP902 Maintenance Phase trial medication) and either completed SP902 or met an exit criterion in SP902; subject is allowed up to 2 concomitant Antiepileptic Drugs (AEDs) Exclusion Criteria: * Subject meets the withdrawal criteria (excluding exit criteria) for the SP902 trial, or is experiencing an ongoing Serious Adverse Event (SAE)

Locations (108)

Outcomes

Primary Outcomes

Percentage of Subjects on Lacosamide (LCM) Monotherapy at Any Time Between Visit 1 and End of Study

Percentage of Subjects on Lacosamide (LCM) Monotherapy at any time between Visit 1 and End of Study.

Time frame: From Visit 1 to End of Study (approximately 2 years)

Duration of Lacosamide (LCM) Monotherapy Treatment From Visit 1 to End of Study

Duration of total Lacosamide Monotherapy From Visit 1 to End of Study.

Time frame: From Visit 1 to End of Study (approximately 2 years)

Secondary Outcomes

Occurrence of At Least One Treatment-Emergent Adverse Event (TEAE) From Visit 1 to End of Study

A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases. An TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design).

Time frame: From Visit 1 to End of Study (approximately 2 years)

Occurrence of Treatment-Emergent Adverse Events (TEAE) Leading to Subject Withdrawal From Visit 1 to End of Study

Time frame: From Visit 1 to End of Study (approximately 2 years)

Data from ClinicalTrials.gov

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048

Alabaster, Alabama, United States

010

Birmingham, Alabama, United States

042

Northport, Alabama, United States

009

Phoenix, Arizona, United States

014

Phoenix, Arizona, United States

151

Phoenix, Arizona, United States

103

Tucson, Arizona, United States

102

Jonesboro, Arkansas, United States

007

Little Rock, Arkansas, United States

086

Little Rock, Arkansas, United States

...and 98 more locations