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Trial to Assess Long-term Lacosamide (LCM) Monotherapy Use and Safety of LCM Monotherapy and Adjunctive Therapy for Partial-onset Seizures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00530855
First received: September 14, 2007
Last updated: May 18, 2015
Last verified: May 2015
Results First Received: May 18, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Epilepsy
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
This Multicenter, Open-Label Study started to enroll Subjects in February 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participant Flow refers to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.

Reporting Groups
  Description
Lacosamide Lacosamide tablets for dosing 100 -800 mg/day

Participant Flow:   Overall Study
    Lacosamide
STARTED   322 
COMPLETED   210 
NOT COMPLETED   112 
Lack of Efficacy                20 
Withdrawal by Subject                30 
Fatal Serious AE                3 
Non Fatal Serious AE                7 
Non Fatal Non Serious AE                12 
Protocol Violation                3 
Unsatisfactory compliance of subject                11 
Lost to Follow-up                9 
Other reason for premature termination                17 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline Characteristics refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.

Reporting Groups
  Description
Lacosamide Lacosamide tablets for dosing 100 -800 mg/day

Baseline Measures
   Lacosamide 
Overall Participants Analyzed 
[Units: Participants]
 322 
Age 
[Units: Participants]
 
<=18 years   8 
Between 18 and 65 years   301 
>=65 years   13 
Age 
[Units: Years]
Mean (Standard Deviation)
 
mean (standard deviation)   40.7  (13.3) 
Gender 
[Units: Participants]
 
Female   161 
Male   161 
Race/Ethnicity, Customized 
[Units: Participants]
 
White   258 
Black or African American   46 
Asian   1 
Other   17 


  Outcome Measures
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1.  Primary:   Percentage of Subjects on Lacosamide (LCM) Monotherapy at Any Time Between Visit 1 and End of Study   [ Time Frame: From Visit 1 to End of Study (approximately 2 years) ]

2.  Primary:   Duration of Lacosamide (LCM) Monotherapy Treatment From Visit 1 to End of Study   [ Time Frame: From Visit 1 to End of Study (approximately 2 years) ]

3.  Secondary:   Occurrence of At Least One Treatment-Emergent Adverse Event (TEAE) From Visit 1 to End of Study   [ Time Frame: From Visit 1 to End of Study (approximately 2 years) ]

4.  Secondary:   Occurrence of Treatment-Emergent Adverse Events (TEAE) Leading to Subject Withdrawal From Visit 1 to End of Study   [ Time Frame: From Visit 1 to End of Study (approximately 2 years) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: UCB Clinical Trial Call Center
Organization: UCB Pharma
phone: +1 877 822 9493



Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00530855     History of Changes
Other Study ID Numbers: SP0904
2007-005440-25 ( EudraCT Number )
Study First Received: September 14, 2007
Results First Received: May 18, 2015
Last Updated: May 18, 2015