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

• ClinicalTrials.gov Identifier: NCT00655551
• Recruitment Status: Completed
• First Posted: April 10, 2008
• Results First Posted: October 20, 2010
• Last Update Posted: July 17, 2018
• Sponsor: UCB BIOSCIENCES, Inc.
• Information provided by (Responsible Party): UCB Pharma ( UCB BIOSCIENCES, Inc. )

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Partial Epilepsies; Partial Onset Seizures	Drug: lacosamide	Phase 3

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Detailed Description:

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Open-label Trial to Assess the Safety and Tolerability of a Single Intravenous Loading Dose of Lacosamide Followed by Oral Lacosamide Maintenance as Adjunctive Therapy in Subjects With Partial-onset Seizures
• Study Start Date: April 2008
• Actual Primary Completion Date: September 2009
• Actual Study Completion Date: September 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: Lacosamide 200 mg cohort; Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily	Drug: lacosamide; 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; Other Name: Vimpat
Experimental: Lacosamide 300 mg combined cohorts; Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily	Drug: lacosamide; 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; Other Name: Vimpat
Experimental: Lacosamide 400 mg cohort; Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily	Drug: lacosamide; 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; Other Name: Vimpat

Outcome Measures

Primary Outcome Measures :

1. Number of Subjects With at Least One Adverse Event During the Treatment Period (up to 7 Days) [ Time Frame: 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).
2. Number of Subjects Who Withdrew From the Trial Due to an Adverse Event [ Time Frame: Entire trial period (up to 6 weeks), screening through safety follow-up period (2 weeks post last medication) ]
   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).

Secondary Outcome Measures :

1. Number of Subjects With at Least One Adverse Event With an Onset Within 4 Hours of Start of Infusion [ Time Frame: 0-4 hours post start of the 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).

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 60 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Arizona

Phoenix, Arizona, United States

United States, Maryland

Baltimore, Maryland, United States

United States, Missouri

Chesterfield, Missouri, United States

United States, Ohio

Columbus, Ohio, United States

United States, Pennsylvania

Philadelphia, Pennsylvania, United States

United States, Texas

Dallas, Texas, United States

United States, Virginia

Charlottesville, Virginia, United States

Sponsors and Collaborators

UCB BIOSCIENCES, Inc.

Investigators

• Study Director: UCB Clinical Trial Call Center; +1 877 822 9493 (UCB)

More Information

Additional Information:

FDA Safety Alerts and Recalls 

Product Information 

Publications of Results:

Fountain NB, Krauss G, Isojarvi J, Dilley D, Doty P, Rudd GD. Safety and tolerability of adjunctive lacosamide intravenous loading dose in lacosamide-naive patients with partial-onset seizures. Epilepsia. 2013 Jan;54(1):58-65. doi: 10.1111/j.1528-1167.2012.03543.x. Epub 2012 Jun 18.

• Responsible Party: UCB BIOSCIENCES, Inc.
• ClinicalTrials.gov Identifier: NCT00655551
• Other Study ID Numbers: SP0925; 2014-004378-40 ( EudraCT Number )
• First Posted: April 10, 2008
• Results First Posted: October 20, 2010
• Last Update Posted: July 17, 2018
• Last Verified: July 2017

Keywords provided by UCB Pharma ( UCB BIOSCIENCES, Inc. ):

epilepsy; seizures; Lacosamide; Vimpat; intravenous

Additional relevant MeSH terms:

Epilepsy; Seizures; Epilepsies, Partial; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Lacosamide; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action