Back to resultsStudy to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset Seizures
Primary Purpose
Partial Epilepsies, Partial Onset Seizures
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
lacosamide
Sponsored by
About this trial
This is an interventional treatment trial for Partial Epilepsies focused on measuring Epilepsy, seizures, antiepileptic, Lacosamide, Vimpat, safety, adjunctive
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lacosamide
Arm Description
Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
Outcomes
Primary Outcome Measures
Number of Subjects With at Least One Adverse Event During This Open-label Extension Study (Maximum Study Duration 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)
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00655486
Brief Title
Study to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset Seizures
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB BIOSCIENCES, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Epilepsies, Partial Onset Seizures
Keywords
Epilepsy, seizures, antiepileptic, Lacosamide, Vimpat, safety, adjunctive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lacosamide
Arm Type
Experimental
Arm Description
Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
Intervention Type
Drug
Intervention Name(s)
lacosamide
Other Intervention Name(s)
Vimpat
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of Subjects With at Least One Adverse Event During This Open-label Extension Study (Maximum Study Duration 2 Years)
Description
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).
Time Frame
2 years
Title
Number of Subjects Who Withdrew From the Study Due to an Adverse Event (Maximum Study Duration 2 Years)
Description
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).
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
City
Phoenix
State/Province
Arizona
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Chesterfield
State/Province
Missouri
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Charlottesville
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
Study to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset Seizures
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