Assess Safety and Efficacy of Lacosamide in Patients With Partial Seizures
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00515619 |
Recruitment Status :
Completed
First Posted : August 14, 2007
Results First Posted : September 9, 2011
Last Update Posted : August 28, 2017
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Sponsor:
UCB Pharma
Information provided by (Responsible Party):
UCB Pharma
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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 | 376 |
Participant Flow
Recruitment Details | The study was started in December of 2004 with recruitment occurring in Australia, Croatia, Czech Republic, Finland, France, Germany, Hungary, Lithuania, Poland, Russia, Spain, Sweden, and the United Kingdom. The study had last patient last visit in August of 2010. |
Pre-assignment Details | Safety Set consists of all subjects who received at least 1 dose of Lacosamide. |
Arm/Group Title | Lacosamide |
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50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing) |
Period Title: Overall Study | |
Started | 376 |
Safety Set | 376 |
Completed | 160 |
Not Completed | 216 |
Reason Not Completed | |
Adverse Event | 34 |
Lack of Efficacy | 92 |
Withdrawal by Subject | 66 |
Protocol Violation | 3 |
Lost to Follow-up | 4 |
Unsatisfactory compliance | 6 |
Other: Site discontinuing trials | 2 |
Other: Subject cannot attend visits | 2 |
Other: Subject required surgery | 1 |
Other: Subject moved to another country | 1 |
Other: Investigator decision | 1 |
Other: Subject became pregnant | 1 |
Other: Request from sponsor | 1 |
Other: Drug available on license | 1 |
Other: Subject interested in other AED | 1 |
Baseline Characteristics
Arm/Group Title | Lacosamide | |
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50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing) | |
Overall Number of Baseline Participants | 376 | |
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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 | 376 participants | |
<=18 years |
7 1.9%
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Between 18 and 65 years |
366 97.3%
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>=65 years |
3 0.8%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 376 participants | |
37.8 (11.53) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 376 participants | |
Female |
169 44.9%
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Male |
207 55.1%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 376 participants |
Finland | 16 | |
Spain | 26 | |
Lithuania | 42 | |
Russian Federation | 31 | |
United Kingdom | 20 | |
France | 10 | |
Czech Republic | 50 | |
Hungary | 31 | |
Poland | 37 | |
Croatia | 31 | |
Australia | 31 | |
Germany | 35 | |
Sweden | 16 |
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 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 the results shall be published regardless of outcome.
Results Point of Contact
Name/Title: | UCB (Study Director) |
Organization: | UCB Clinical Trial Call Center |
Phone: | +1 887 822 9493 |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | UCB Pharma |
ClinicalTrials.gov Identifier: | NCT00515619 |
Other Study ID Numbers: |
SP0774 2004-000152-16 ( EudraCT Number ) |
First Submitted: | August 13, 2007 |
First Posted: | August 14, 2007 |
Results First Submitted: | August 5, 2011 |
Results First Posted: | September 9, 2011 |
Last Update Posted: | August 28, 2017 |