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Trial record 1 of 2 for:    NCT00655551
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Safety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures

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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:
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )

Tracking Information
First Submitted Date  ICMJE March 26, 2008
First Posted Date  ICMJE April 10, 2008
Results First Submitted Date  ICMJE September 23, 2010
Results First Posted Date  ICMJE October 20, 2010
Last Update Posted Date July 17, 2018
Study Start Date  ICMJE April 2008
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2010)
  • 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).
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: April 9, 2008)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2010)
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).
Original Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2008)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Partial Epilepsies
  • Partial Onset Seizures
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 9, 2008)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00655551
Other Study ID Numbers  ICMJE SP0925
2014-004378-40 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma ( UCB BIOSCIENCES, Inc. )
Study Sponsor  ICMJE UCB BIOSCIENCES, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
PRS Account UCB Pharma
Verification Date July 2017

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