Trial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures
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ClinicalTrials.gov Identifier: NCT00955357 |
Recruitment Status :
Completed
First Posted : August 10, 2009
Results First Posted : May 1, 2014
Last Update Posted : July 17, 2018
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Partial Epilepsies |
Intervention |
Drug: Lacosamide |
Enrollment | 461 |
Recruitment Details | An estimated 656 subjects were to be enrolled in the study at approximately 130 sites in the US, Europe, and the rest of the world. |
Pre-assignment Details | Overall 461 subjects were enrolled. The Participant Flow refers to the Safety Set (SS) which was defined as all enrolled subjects who took at least 1 dose of Lacosamide. Reasons for discontinuation were only calculated for the SS. 456 subjects were included in the Safety Set. |
Arm/Group Title | First Add-on | Later Add-on |
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Lacosamide added to first adequate monotherapy (no history of Anti-Epileptic Drug [AED] polytherapy) and epilepsy diagnosis < or = 24 months at Screening. Lacosamide: oral tablet Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week |
Lacosamide added to 1 to 3 Anti-Epileptic Drugs (AEDs) (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis > or = 5 years at Screening. Lacosamide: oral tablet Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week |
Period Title: Titration Phase | ||
Started | 96 | 360 |
Completed | 80 | 294 |
Not Completed | 16 | 66 |
Reason Not Completed | ||
Adverse Event | 9 | 46 |
Lack of Efficacy | 0 | 2 |
Protocol Violation | 3 | 7 |
Lost to Follow-up | 1 | 3 |
Withdrawal by Subject | 3 | 5 |
Prohibited Antiepileptic Drug change | 0 | 1 |
Study medication not tolerated | 0 | 1 |
Non compliance to study procedures | 0 | 1 |
Period Title: Maintenance Phase | ||
Started | 80 | 294 |
Completed | 68 | 249 |
Not Completed | 12 | 45 |
Reason Not Completed | ||
Adverse Event | 3 | 23 |
Lack of Efficacy | 0 | 4 |
Protocol Violation | 2 | 6 |
Lost to Follow-up | 2 | 7 |
Withdrawal by Subject | 4 | 4 |
Patient moving out of area | 0 | 1 |
Non compliance to study procedures | 1 | 0 |
Arm/Group Title | First Add-on | Later-Add-on | Total | |
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Lacosamide added to first adequate monotherapy (no history of AED polytherapy) and epilepsy diagnosis < or = 24 months at Screening. Lacosamide: oral tablet Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week |
Lacosamide added to 1 to 3 AEDs (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis > or = 5 years at Screening. Lacosamide: oral tablet Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week |
Total of all reporting groups | |
Overall Number of Baseline Participants | 96 | 360 | 456 | |
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The Baseline Analysis Population refers to the Safety Set (SS) which includes all enrolled subjects who took at least one dose of study medication. 5 subjects at one site were excluded from the Safety Set due to significant study conduct deficiencies.
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 96 participants | 360 participants | 456 participants | |
37.5
(18.0 to 82.0)
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38.0
(16.0 to 74.0)
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38.0
(16.0 to 82.0)
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 96 participants | 360 participants | 456 participants | |
<=18 years |
4 4.2%
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7 1.9%
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11 2.4%
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Between 18 and 65 years |
82 85.4%
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349 96.9%
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431 94.5%
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>=65 years |
10 10.4%
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4 1.1%
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14 3.1%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 96 participants | 360 participants | 456 participants | |
Female |
53 55.2%
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180 50.0%
|
233 51.1%
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Male |
43 44.8%
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180 50.0%
|
223 48.9%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 96 participants | 360 participants | 456 participants | |
American Indian or Alaska Native |
11 11.5%
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6 1.7%
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17 3.7%
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|
Asian |
0 0.0%
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12 3.3%
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12 2.6%
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|
Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
1 1.0%
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19 5.3%
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20 4.4%
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White |
79 82.3%
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278 77.2%
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357 78.3%
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More than one race |
5 5.2%
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45 12.5%
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50 11.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 96 participants | 360 participants | 456 participants | |
Hispanic or Latino |
24 25.0%
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99 27.5%
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123 27.0%
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Not Hispanic or Latino |
72 75.0%
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261 72.5%
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333 73.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
|
0 0.0%
|
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Weight
Median (Full Range) Unit of measure: Kilogram |
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Number Analyzed | 96 participants | 360 participants | 456 participants | |
71.8
(42.0 to 132.9)
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73.0
(41.9 to 147.4)
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73.0
(41.9 to 147.4)
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Height
Median (Full Range) Unit of measure: Centimeter |
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Number Analyzed | 96 participants | 360 participants | 456 participants | |
166.5
(149.0 to 186.0)
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167.6
(140.0 to 197.0)
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167.6
(140.0 to 197.0)
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BMI
Median (Full Range) Unit of measure: Kilogram per m^2 |
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Number Analyzed | 96 participants | 360 participants | 456 participants | |
25.3
(14.5 to 42.5)
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25.5
(17.3 to 53.9)
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25.4
(14.5 to 53.9)
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Name/Title: | UCB Clinical Trial Call Center |
Organization: | UCB |
Phone: | +1 877 822 9493 |
Responsible Party: | UCB Pharma |
ClinicalTrials.gov Identifier: | NCT00955357 |
Other Study ID Numbers: |
SP0954 2009-011181-28 ( EudraCT Number ) |
First Submitted: | August 6, 2009 |
First Posted: | August 10, 2009 |
Results First Submitted: | March 28, 2014 |
Results First Posted: | May 1, 2014 |
Last Update Posted: | July 17, 2018 |