Back to resultsDetermine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures
Primary Purpose
Partial Epilepsies
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 Adjunctive treatment in epilepsy, add-on treatment for epilepsy, partial seizures, AEDs, antiepileptic drugs, seizures
Eligibility Criteria
Inclusion Criteria:
- Completion of parent clinical trial for treatment of partial seizures
Exclusion Criteria:
- Receiving any study drug or experimental device other than lacosamide
- Meets withdrawal criteria for parent trial or experiencing ongoing serious adverse event
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lacosamide
Arm Description
Up to 800 mg/day lacosamide (flexible dosing)
Outcomes
Primary Outcome Measures
Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 6 Years)
Serious adverse events are any untoward serious medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Secondary Outcome Measures
Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years)
Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.
Percentage of at Least 50 % Responders During the Treatment Period (Maximum 6 Years)
At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00522275
Brief Title
Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures
Official Title
An Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral SPM 927 in Patients With Partial Seizures
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (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 trial is to determine whether lacosamide is safe and effective for long-term use in patients with partial-seizures from epilepsy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Epilepsies
Keywords
Adjunctive treatment in epilepsy, add-on treatment for epilepsy, partial seizures, AEDs, antiepileptic drugs, seizures
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
308 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lacosamide
Arm Type
Experimental
Arm Description
Up to 800 mg/day lacosamide (flexible dosing)
Intervention Type
Drug
Intervention Name(s)
lacosamide
Intervention Description
50mg or 100 mg tablets, up to 800 mg/day given twice daily (BID) throughout the trial
Primary Outcome Measure Information:
Title
Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)
Description
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time Frame
During the Treatment Period (Maximum 6 years)
Title
Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)
Description
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time Frame
During the Treatment Period (Maximum 6 years)
Title
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 6 Years)
Description
Serious adverse events are any untoward serious medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time Frame
During the Treatment Period (Maximum 6 years)
Secondary Outcome Measure Information:
Title
Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years)
Description
Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.
Time Frame
Baseline (8-week Baseline Period from the parent study SP0754 [NCT00136019]), Treatment Period (Maximum 6 years)
Title
Percentage of at Least 50 % Responders During the Treatment Period (Maximum 6 Years)
Description
At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study.
Time Frame
Treatment Period (Maximum 6 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Completion of parent clinical trial for treatment of partial seizures
Exclusion Criteria:
Receiving any study drug or experimental device other than lacosamide
Meets withdrawal criteria for parent trial or 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
Birmingham
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United States
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Mobile
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United States
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Phoenix
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Little Rock
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Los Angeles
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San Francisco
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Englewood
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Fairfield
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Bradenton
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Jacksonville
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Maitland
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Indianapolis
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Lexington
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Louisville
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Baltimore
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Bethesda
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Saint Cloud
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Saint Paul
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Chesterfield
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Buffalo
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Rochester
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Syracuse
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Greenville
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Winston-Salem
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Cincinnati
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Cleveland
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Columbus
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Toledo
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Tulsa
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Medford
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Hershey
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Philadelphia
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Providence
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Rhode Island
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Beaufort
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Charleston
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Nashville
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Dallas
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San Antonio
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Charlottesville
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Newport News
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Norfolk
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Richmond
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Morgantown
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United States
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Marshfield
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United States
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Milwaukee
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Wisconsin
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United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22372628
Citation
Husain A, Chung S, Faught E, Isojarvi J, McShea C, Doty P. Long-term safety and efficacy in patients with uncontrolled partial-onset seizures treated with adjunctive lacosamide: results from a Phase III open-label extension trial. Epilepsia. 2012 Mar;53(3):521-8. doi: 10.1111/j.1528-1167.2012.03407.x.
Results Reference
result
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
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Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures
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