Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy
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ClinicalTrials.gov Identifier: NCT01118962 |
Recruitment Status :
Completed
First Posted : May 7, 2010
Results First Posted : December 4, 2013
Last Update Posted : July 17, 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 |
Epilepsy |
Intervention |
Drug: Lacosamide |
Enrollment | 39 |
Recruitment Details |
This study began enrollment in August 2010. The study completed in October 2012. The participant flow consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM). |
Pre-assignment Details |
Arm/Group Title | Lacosamide |
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Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949). Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses. |
Period Title: Overall Study | |
Started | 39 |
Completed | 29 |
Not Completed | 10 |
Reason Not Completed | |
Adverse Event | 2 |
Lack of Efficacy | 1 |
Protocol Violation | 1 |
Withdrawal by Subject | 4 |
Pregnancy | 1 |
Non-compliance with Medicinal Product | 1 |
Arm/Group Title | Lacosamide | |
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Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949). Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses. |
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Overall Number of Baseline Participants | 39 | |
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Baseline measurements consist of the Safety Set (SS).
The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 39 participants | |
<=18 years |
3 7.7%
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Between 18 and 65 years |
36 92.3%
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>=65 years |
0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 39 participants | |
30.3 (10.7) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 39 participants | |
Female |
28 71.8%
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Male |
11 28.2%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 39 participants |
39 | ||
Weight
Mean (Standard Deviation) Unit of measure: Kilograms |
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Number Analyzed | 39 participants | |
77.66 (17.58) | ||
Height
Mean (Standard Deviation) Unit of measure: Centimeters |
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Number Analyzed | 39 participants | |
167.88 (8.25) |
Name/Title: | UCB (Study Director) |
Organization: | UCB Clinical Trial Call Center |
Phone: | +1 887 822 9493 |
Responsible Party: | UCB Pharma ( UCB BIOSCIENCES, Inc. ) |
ClinicalTrials.gov Identifier: | NCT01118962 |
Other Study ID Numbers: |
SP0962 2014-004375-23 ( EudraCT Number ) |
First Submitted: | May 5, 2010 |
First Posted: | May 7, 2010 |
Results First Submitted: | October 7, 2013 |
Results First Posted: | December 4, 2013 |
Last Update Posted: | July 17, 2018 |