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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00655551
First received: March 26, 2008
Last updated: February 8, 2013
Last verified: September 2011
  Purpose

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 Intervention Phase
Partial Epilepsies
Partial Onset Seizures
Drug: lacosamide
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase IIIb, 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

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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).

  • 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) ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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).


Enrollment: 100
Study Start Date: April 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Both
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 AEDs 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
  • Nonepileptic events, including psychogenic seizures that could be confused with seizures
  • Use of neuroleptics, MOA 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655551

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, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
Publications:
Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00655551     History of Changes
Other Study ID Numbers: SP925
Study First Received: March 26, 2008
Results First Received: September 23, 2010
Last Updated: February 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by UCB, Inc.:
epilepsy
seizures
Lacosamide
Vimpat
intravenous

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014