Study to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset Seizures
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| ClinicalTrials.gov Identifier: NCT00655486 |
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Recruitment Status :
Completed
First Posted : April 10, 2008
Results First Posted : July 15, 2011
Last Update Posted : July 17, 2018
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Sponsor:
UCB BIOSCIENCES, Inc.
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Conditions |
Partial Epilepsies Partial Onset Seizures |
| Intervention |
Drug: lacosamide |
| Enrollment | 97 |
Participant Flow
| Recruitment Details | The study started in April 2008 with enrollment occuring in the United States only. The study completed June 2010 |
| Pre-assignment Details |
| Arm/Group Title | Lacosamide |
|---|---|
 Arm/Group Description |
Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years) |
| Period Title: Overall Study | |
| Started | 97 |
| Completed | 69 |
| Not Completed | 28 |
| Reason Not Completed | |
| Adverse Event | 10 |
| Lack of Efficacy | 8 |
| Withdrawal by Subject | 4 |
| Protocol Violation | 1 |
| Unsatisfactory compliance | 2 |
| Other: Pregnancy | 1 |
| Other: Could not tolerate BID dosing | 1 |
| Other: Abnormal electrocardiogram (ECG) | 1 |
Baseline Characteristics
| Arm/Group Title | Lacosamide | |
|---|---|---|
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Arm/Group Description |
Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years) | |
| Overall Number of Baseline Participants | 97 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 97 participants | |
| <=18 years |
2 2.1%
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| Between 18 and 65 years |
95 97.9%
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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 | 97 participants | |
| 38.8 (11.71) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 97 participants | |
| Female |
47 48.5%
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| Male |
50 51.5%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| United States | Number Analyzed | 97 participants |
| 97 | ||
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Results Point of Contact
| Name/Title: | UCB Clinical Trial Call Center |
| Organization: | UCB, Inc |
| Phone: | +1 877 822 9493 |
| Responsible Party: | UCB Pharma ( UCB BIOSCIENCES, Inc. ) |
| ClinicalTrials.gov Identifier: | NCT00655486 |
| Other Study ID Numbers: |
SP0926 2014-004384-21 ( EudraCT Number ) |
| First Submitted: | March 26, 2008 |
| First Posted: | April 10, 2008 |
| Results First Submitted: | June 15, 2011 |
| Results First Posted: | July 15, 2011 |
| Last Update Posted: | July 17, 2018 |