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Study to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset Seizures

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ClinicalTrials.gov Identifier: NCT00655486
Recruitment Status : Completed
First Posted : April 10, 2008
Results First Posted : July 15, 2011
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 June 15, 2011
Results First Posted Date  ICMJE July 15, 2011
Last Update Posted Date July 17, 2018
Study Start Date  ICMJE April 2008
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2011)
  • Number of Subjects With at Least One Adverse Event During This Open-label Extension Study (Maximum Study Duration 2 Years) [ Time Frame: 2 years ]
    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 Study Due to an Adverse Event (Maximum Study Duration 2 Years) [ Time Frame: 2 years ]
    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 4, 2008)
Adverse events reported spontaneously by the subject or observed by the investigator; withdrawals due to adverse events. [ Time Frame: During periodic clinical visits over approximately 2 years ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2008)
Changes in hematology, chemistry, urinalysis, ECGs, vital signs and body weight [ Time Frame: During periodic clinical visits over approximately 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset Seizures
Official Title  ICMJE A Multicenter, Open-label Extension Trial to Assess the Long-term Safety and Tolerability of Lacosamide as Adjunctive Therapy in Subjects With Partial-onset Seizures
Brief Summary The purpose of this study is to allow eligible subjects from the parent study, SP925 [NCT00655551] to continue lacosamide and to obtain additional long-term safety data
Detailed Description A multicenter, open-label extension study to assess the long-term safety and tolerability of lacosamide as adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the SP925 study [NCT00655551] (intravenous lacosamide loading dose followed by approximately 1 week of oral lacosamide maintenance).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Partial Epilepsies
  • Partial Onset Seizures
Intervention  ICMJE Drug: lacosamide
Subjects' dose of lacosamide may be increased or decreased as needed to maintain a subject's effective and tolerable dose during the study. Tablets are 50 mg or 100 mg each; Dose is 100 mg/day up to 800 mg/day administered twice daily throughout the study (up to 2 years).
Other Name: Vimpat
Study Arms  ICMJE Experimental: Lacosamide
Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
Intervention: Drug: lacosamide
Publications * Not Provided

*   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: October 16, 2009)
97
Original Estimated Enrollment  ICMJE
 (submitted: April 4, 2008)
100
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Eligible subjects who participated in SP925 [NCT00655551] for treatment of partial-onset seizures

Exclusion Criteria:

  • Receiving any study drug or experimental device other than lacosamide
  • Meets withdrawal criteria for parent study SP925 [NCT00655551]
  • Experiencing ongoing serious adverse event
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 NCT00655486
Other Study ID Numbers  ICMJE SP0926
2014-004384-21 ( EudraCT Number )
Has Data Monitoring Committee No
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