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Trial to Assess the Safety of a Single Dose of iv Lacosamide Followed by Twice Daily Oral Lacosamide in Patients With Partial-Onset Seizures

This study is currently recruiting participants.
Verified by UCB, August 2008

Sponsored by: UCB
Information provided by: UCB
ClinicalTrials.gov Identifier: NCT00655551
  Purpose

The purpose of the trial is to evaluate the safety of iv lacosamide delivered in a single dose followed by 6,5 days of oral dosing with lacosamide in patients with partial-onset seizures.


Condition Intervention Phase
Partial Epilepsies
Drug: lacosamide
Phase III

Genetics Home Reference related topics:   autosomal dominant partial epilepsy with auditory features    pyridoxal 5'-phosphate-dependent epilepsy   

MedlinePlus related topics:   Epilepsy    Seizures   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
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

Further study details as provided by UCB:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment:   100
Study Start Date:   March 2008
Estimated Study Completion Date:   September 2009
Estimated Primary Completion Date:   September 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
One bolus dose of iv lacosamide followed by 6.5 days of oral lacosamide
Drug: lacosamide
iv lacosamide 200mg one bolus dose administered over a 15 minute infusion duration followed by oral lacosamide 200mg/day (100mg bid) for 6.5 days
2: Experimental
One bolus dose of iv lacosamide followed by 6.5 days of oral lacosamide
Drug: lacosamide
iv lacosamide 300mg one bolus dose administered over a 15 minute infusion duration followed by oral lacosamide300mg/day (150mg bid) for 6.5 days
3: Experimental
One bolus dose of iv lacosamide followed by 6.5 days of oral lacosamide
Drug: lacosamide
iv lacosamide 400mg one bolus dose administered over a 15 minute infusion duration followed by oral lacosamide 400mg/day (200mg bid) for 6.5 days
4: Experimental
One bolus dose of iv lacosamide followed by 6.5 days of oral lacosamide
Drug: lacosamide
TBD A DMC review will determine if the trial should be ended or which of the 3 cohorts will be repeated. The repeated cohort will be the highest dose that produces clinically acceptable safety results.

Detailed Description:

A multicenter, open-label trial designed to assess the safety and tolerability of rapid initiation of adjunctive lacosamide via a single iv loading dose (iv lacosamide 200mg, 300mg, or 400mg administered over a 15-minute infusion duration) followed by twice daily oral lacosamide dosing (daily dose equivalent to the iv loading dose) in adults subjects 16 - 60 years of age with partial-onset seizures.

  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 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

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

Contacts
Contact: UCB Clinical Trial Call Center     +1 877 822 9493    

Locations
United States, Maryland
Recruiting
      Baltimore, Maryland, United States
United States, Missouri
Recruiting
      Chesterfield, Missouri, United States
United States, Ohio
Recruiting
      Columbus, Ohio, United States
Recruiting
      Cleveland, Ohio, United States
United States, Pennsylvania
Recruiting
      Philadelphia, Pennsylvania, United States
United States, Tennessee
Active, not recruiting
      Nashville, Tennessee, United States
United States, Texas
Recruiting
      Dallas, Texas, United States
United States, Virginia
Recruiting
      Charlottesville, Virginia, United States

Sponsors and Collaborators
UCB

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


Responsible Party:   UCB ( Study Director )
Study ID Numbers:   SP925
First Received:   March 26, 2008
Last Updated:   August 19, 2008
ClinicalTrials.gov Identifier:   NCT00655551
Health Authority:   United States: Food and Drug Administration

Keywords provided by UCB:
Adjunctive treatment in epilepsy  
add-on treatment for epilepsy  
partial seizures  
AEDs  
antiepileptic drugs
seizures
Vimpat
iv AED

Study placed in the following topic categories:
Epilepsies, Partial
Epilepsy
Seizures
Central Nervous System Diseases
Brain Diseases

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on October 10, 2008




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