Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures (ALEX-MT)
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ClinicalTrials.gov Identifier: NCT00520741 |
Recruitment Status :
Completed
First Posted : August 27, 2007
Results First Posted : April 23, 2014
Last Update Posted : July 19, 2018
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
Condition |
Epilepsy |
Intervention |
Drug: Lacosamide |
Enrollment | 426 |
Recruitment Details |
The study was conducted at 160 sites in the United States of America (USA), Canada, Europe, and Australia.The maximum duration of a subject's trial participation is 30 weeks. The Participant Flow refers to the Safety Set (SS) population which consists of all patients who received at least one dose of study medication. |
Pre-assignment Details | Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control. |
Arm/Group Title | Lacosamide 300 mg/Day | Lacosamide 400 mg/Day |
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Lacosamide 300 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control. |
Lacosamide 400 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control. |
Period Title: Overall Study | ||
Started | 106 | 319 [1] |
Completed | 69 | 194 |
Not Completed | 37 | 125 |
Reason Not Completed | ||
Adverse Event | 16 | 56 |
Lack of Efficacy | 11 | 30 |
Withdrawal by Subject | 0 | 11 |
Protocol Violation | 2 | 15 |
Unsatisfactory compliance of subject | 4 | 3 |
Lost to Follow-up | 4 | 4 |
Other reasons for premature termination | 0 | 6 |
[1]
One subject was randomized at 2 sites and excluded from the Safety Set.
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Arm/Group Title | Lacosamide 300 mg/Day | Lacosamide 400 mg/Day | Total | |
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Lacosamide 300 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control. |
Lacosamide 400 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control. |
Total of all reporting groups | |
Overall Number of Baseline Participants | 106 | 319 | 425 | |
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The Baseline Analysis Population refers to the Safety Set (SS) which includes the unique randomized subjects who took at least one dose of study medication.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 106 participants | 319 participants | 425 participants | |
<=18 years |
3 2.8%
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7 2.2%
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10 2.4%
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Between 18 and 65 years |
99 93.4%
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303 95.0%
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402 94.6%
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>=65 years |
4 3.8%
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9 2.8%
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13 3.1%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 106 participants | 319 participants | 425 participants | |
41.4 (14.3) | 40.4 (12.5) | 40.6 (13.0) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 106 participants | 319 participants | 425 participants | |
Female |
50 47.2%
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169 53.0%
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219 51.5%
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Male |
56 52.8%
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150 47.0%
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206 48.5%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 106 participants | 319 participants | 425 participants |
White | 91 | 246 | 337 | |
Black | 9 | 53 | 62 | |
Asian | 0 | 1 | 1 | |
Other | 6 | 19 | 25 | |
Height
Mean (Standard Deviation) Unit of measure: Centimeter |
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Number Analyzed | 106 participants | 319 participants | 425 participants | |
169.72 (10.69) | 169.01 (10.87) | 169.19 (10.82) | ||
Weight
Mean (Standard Deviation) Unit of measure: Kilogram |
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Number Analyzed | 106 participants | 319 participants | 425 participants | |
81.62 (19.53) | 82.13 (21.30) | 82.00 (20.85) | ||
Body Mass Index (BMI)
Mean (Standard Deviation) Unit of measure: Kg/m^2 |
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Number Analyzed | 106 participants | 319 participants | 425 participants | |
28.22 (5.74) | 28.67 (6.64) | 28.56 (6.42) | ||
Average Baseline Seizure Frequency per 28 days
Mean (Standard Deviation) Unit of measure: Seizures/28 days |
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Number Analyzed | 106 participants | 319 participants | 425 participants | |
10.10 (8.82) | 10.22 (8.88) | 10.19 (8.86) |
Name/Title: | UCB Clinical Trial Call Center |
Organization: | UCB |
Phone: | +1 877 822 9493 |
Responsible Party: | UCB Pharma ( UCB BIOSCIENCES, Inc. ) |
ClinicalTrials.gov Identifier: | NCT00520741 |
Obsolete Identifiers: | NCT01058954 |
Other Study ID Numbers: |
SP0902 2007-005439-27 ( EudraCT Number ) |
First Submitted: | August 24, 2007 |
First Posted: | August 27, 2007 |
Results First Submitted: | November 26, 2013 |
Results First Posted: | April 23, 2014 |
Last Update Posted: | July 19, 2018 |