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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00655486
First received: March 26, 2008
Last updated: August 30, 2011
Last verified: July 2011

March 26, 2008
August 30, 2011
April 2008
June 2010   (final data collection date for primary outcome measure)
  • Number of Subjects With at Least One Adverse Event During This Open-label Extension Study (Maximum Study Duration 2 Years) [ Time Frame: 2 years ] [ 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 Study Due to an Adverse Event (Maximum Study Duration 2 Years) [ Time Frame: 2 years ] [ 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 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 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00655486 on ClinicalTrials.gov Archive Site
Not Provided
Changes in hematology, chemistry, urinalysis, ECGs, vital signs and body weight [ Time Frame: During periodic clinical visits over approximately 2 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset Seizures
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

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

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).

Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Partial Epilepsies
  • Partial Onset Seizures
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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
97
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
16 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00655486
SP926
No
UCB, Inc.
UCB, Inc.
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB, Inc.
July 2011

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