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

March 26, 2008
February 8, 2013
April 2008
September 2009   (final data collection date for primary outcome measure)
  • 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).
Adverse events as reported spontaneously by the patient and/or caregiver or observed by the investigator, subject withdrawals due to AEs [ Time Frame: 10 days to up to 6 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00655551 on ClinicalTrials.gov Archive Site
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).
Changes in hematology, chemistry and urinalysis; changes in ECGs and vital signs; plasma concentrations of lacosamide [ Time Frame: 10 days to up to 6 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Safety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures
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

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Partial Epilepsies
  • Partial Onset Seizures
  • 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
  • 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
  • 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
  • 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
    Intervention: Drug: lacosamide
  • 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
    Intervention: Drug: lacosamide
  • 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
    Intervention: Drug: lacosamide
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. PubMed PMID: 22708895.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
16 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00655551
SP925
Yes
UCB, Inc.
UCB, Inc.
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB, Inc.
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP