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Safety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00655551
First received: March 26, 2008
Last updated: February 8, 2013
Last verified: September 2011
History of Changes
Results First Received: September 23, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Partial Epilepsies
Partial Onset Seizures
Intervention: Drug: lacosamide

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Lacosamide (200 mg) Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
Lacosamide (300 mg) Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
Lacosamide (400 mg) Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily

Participant Flow for 5 periods

 Period 1:   All Periods Combined
    Lacosamide (200 mg)     Lacosamide (300 mg)     Lacosamide (400 mg)  
STARTED     25     50     25  
COMPLETED     25     47     21  
NOT COMPLETED     0     3     4  
Adverse Event                 0                 3                 4  

Period 2:   Period 1 (up to 7 Days)
    Lacosamide (200 mg)     Lacosamide (300 mg)     Lacosamide (400 mg)  
STARTED     25     0     0  
COMPLETED     25     0     0  
NOT COMPLETED     0     0     0  

Period 3:   Period 2 (up to 7 Days)
    Lacosamide (200 mg)     Lacosamide (300 mg)     Lacosamide (400 mg)  
STARTED     0     25     0  
COMPLETED     0     24     0  
NOT COMPLETED     0     1     0  
Adverse Event                 0                 1                 0  

Period 4:   Period 3 (up to 7 Days)
    Lacosamide (200 mg)     Lacosamide (300 mg)     Lacosamide (400 mg)  
STARTED     0     0     25  
COMPLETED     0     0     21  
NOT COMPLETED     0     0     4  
Adverse Event                 0                 0                 4  

Period 5:   Period 4 (up to 7 Days)
    Lacosamide (200 mg)     Lacosamide (300 mg)     Lacosamide (400 mg)  
STARTED     0     25     0  
COMPLETED     0     23     0  
NOT COMPLETED     0     2     0  
Adverse Event                 0                 2                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Lacosamide (200 mg) Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
Lacosamide (300 mg) Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
Lacosamide (400 mg) Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
Total Total of all reporting groups

Baseline Measures
    Lacosamide (200 mg)     Lacosamide (300 mg)     Lacosamide (400 mg)     Total  
Number of Participants  
[units: participants]
 		  25     50     25     100  
Age  
[units: participants]
 		       
<=18 years     0     2     0     2  
Between 18 and 65 years     25     48     25     98  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  39.1  ± 11.77     38.6  ± 11.53     39.6  ± 12.24     39.0  ± 11.66  
Gender  
[units: participants]
 		       
Female     14     26     9     49  
Male     11     24     16     51  
Region of Enrollment  
[units: participants]
 		       
United States     25     50     25     100  



  Outcome Measures
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1.  Primary:   Number of Subjects With at Least One Adverse Event During the Treatment Period (up to 7 Days)   [ Time Frame: Treatment period (up to 7 days) ]
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2.  Primary:   Number of Subjects Who Withdrew From the Trial Due to an Adverse Event   [ Time Frame: Entire trial period (up to 6 weeks), screening through safety follow-up period (2 weeks post last medication) ]
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3.  Secondary:   Number of Subjects With at Least One Adverse Event With an Onset Within 4 Hours of Start of Infusion   [ Time Frame: 0-4 hours post start of the infusion ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: UCB Clinical Trial Call Center
Organization: UCB, Inc
phone: +1 877 822 9493


Publications of Results:


Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00655551     History of Changes
Other Study ID Numbers: SP925
Study First Received: March 26, 2008
Results First Received: September 23, 2010
Last Updated: February 8, 2013
Health Authority: United States: Food and Drug Administration