Trial to Assess Optimized Dosage of Lacosamide as add-on Therapy in Patients With Partial Onset Seizure (SELF)
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ClinicalTrials.gov Identifier: NCT01235403 |
Recruitment Status :
Completed
First Posted : November 5, 2010
Results First Posted : January 24, 2013
Last Update Posted : May 21, 2018
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Partial Epilepsies |
Intervention |
Drug: Lacosamide |
Enrollment | 100 |
Recruitment Details | This is a 24-week study, which enrolled 100 patients at 44 sites in France. |
Pre-assignment Details |
The study comprises a 12-week Titration Phase and a 12-week Maintenance Phase; both phases together are regarded as the 24-week Treatment Period. Participant Flow and Baseline Characteristics refer to the Safety Set (SS). The SS includes all subjects that received at least one dose of study medication. |
Arm/Group Title | Lacosamide |
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Flexible dosing between 200 mg/day and 400 mg/day Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks. Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day. Taper phase if needed: 3 to 4 weeks |
Period Title: Overall Study | |
Started | 100 |
Completed | 74 |
Not Completed | 26 |
Reason Not Completed | |
Adverse Event | 14 |
Lost to Follow-up | 2 |
Withdrawal by Subject | 4 |
Lack of Efficacy | 2 |
Other reasons for premature termination | 4 |
Arm/Group Title | Lacosamide | |
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Flexible dosing between 200mg/day and 400mg/day Lacosamide: 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks. Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day. Taper phase if needed: 3 to 4 weeks |
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Overall Number of Baseline Participants | 100 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 100 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
88 88.0%
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>=65 years |
12 12.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 100 participants | |
44.5 (16.22) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 100 participants | |
Female |
55 55.0%
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Male |
45 45.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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France | Number Analyzed | 100 participants |
100 |
Name/Title: | UCB Clinical Trial Call Center |
Organization: | UCB |
Phone: | +1 877 822 9493 |
Responsible Party: | UCB Pharma |
ClinicalTrials.gov Identifier: | NCT01235403 |
Other Study ID Numbers: |
SP1007 2010-019268-35 ( EudraCT Number ) |
First Submitted: | November 3, 2010 |
First Posted: | November 5, 2010 |
Results First Submitted: | December 18, 2012 |
Results First Posted: | January 24, 2013 |
Last Update Posted: | May 21, 2018 |