NCT00655551 - Safety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures | Crick

Overview

The purpose of the trial is to evaluate the safety of intravenous (iv) lacosamide delivered in a single dose followed by 6.5 days of oral lacosamide treatment in subjects with partial-onset seizures.

This multicenter, open-label trial examined safety and tolerability of rapid initiation of adjunctive lacosamide via a single intravenous loading dose followed by oral maintenance treatment in subjects 16 - 60 years of age with partial-onset seizures. Three consecutive 25-subject cohorts were given a progressively increasing dose of lacosamide (200, 300, 400 mg) administered as a single 15-minute intravenous (iv) loading dose followed by the equivalent daily dose administered orally twice daily for 6.5 days with the first oral dose 12 hours after the iv dose. A fourth cohort of 25 subjects repeated the 300 mg dose to provide safety data on a total of 50 subjects at the highest well-tolerated dose.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Partial Epilepsies Partial Onset Seizures

Interventions

lacosamideDRUG

Single loading intravenous (iv) lacosamide 200 mg dose administered over a 15 minute infusion duration followed by oral lacosamide 200 mg/day (100 mg twice daily) for 6.5 days

lacosamideDRUG

Single loading intravenous (iv) lacosamide 300 mg dose administered over a 15 minute infusion duration followed by oral lacosamide 300 mg/day (150 mg twice daily) for 6.5 days

lacosamideDRUG

Single loading intravenous (iv) lacosamide 400 mg dose administered over a 15 minute infusion duration followed by oral lacosamide 400 mg/day (200 mg twice daily) for 6.5 days

Eligibility

Sex: ALLMin age: 16 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of epilepsy with simple partial seizures and/or complex partial seizures * Stable dose regimen of 1 to 2 marketed antiepileptic drug(s) (AED(s)) for 28 days prior to screening and duration of trial * Acceptable candidate for venipuncture and intravenous (iv) infusion * At least 1 partial seizure with motor component per 90 days * Maximum allowed seizure frequency during 28 days prior to screening is 40 partial seizures of any type Exclusion Criteria: * Previous use of lacosamide * History of primary generalized seizures * History of status epilepticus within last 12 months * History of cluster seizures during 8 week period prior to screening * Non-epileptic events, including psychogenic seizures that could be confused with seizures * Use of neuroleptics, monoamine oxidase (MAO) inhibitors, barbiturates, or narcotic analgesics within 28 days prior to screening * Received any rescue benzodiazepines more than once during the 28 days prior to screening * Concomitant treatment of felbamate or previous felbamate therapy within last 6 months * Prior or concomitant vigabatrin use

Locations (7)

Unnamed facility

Phoenix, Arizona, United States

Unnamed facility

Baltimore, Maryland, United States

Unnamed facility

Chesterfield, Missouri, United States

Unnamed facility

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Number of Subjects With at Least One Adverse Event During the Treatment Period (up to 7 Days)

An Adverse Event (AE) is 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 period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).

Time frame: Treatment period (up to 7 days)

Number of Subjects Who Withdrew From the Trial Due to an Adverse Event

An Adverse Event (AE) is 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 period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).

Time frame: Entire trial period (up to 6 weeks), screening through safety follow-up period (2 weeks post last medication)

Secondary Outcomes

Number of Subjects With at Least One Adverse Event With an Onset Within 4 Hours of Start of Infusion

An Adverse Event (AE) is 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 period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).

Time frame: 0-4 hours post start of the infusion