Trial record 1 of 1 for:    NCT00522275
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Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00522275
First received: August 27, 2007
Last updated: February 8, 2013
Last verified: August 2011
Results First Received: October 28, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Partial Epilepsies
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Lacosamide Up to 800 mg/day lacosamide (flexible dosing)

Participant Flow:   Overall Study
    Lacosamide  
STARTED     308  
COMPLETED     138  
NOT COMPLETED     170  
Adverse Event                 35  
Lack of Efficacy                 80  
Subject withdrew consent                 16  
Protocol deviation                 1  
Unsatisfactory compliance                 11  
Lost to Follow-up                 8  
Other: Subject wants to become pregnant                 2  
Other: Subject is pregnant                 2  
Other: Subject relocated                 2  
Other: Subject arrested                 1  
Other: Site / clinic closed                 4  
Other: Travel to / from site difficulty                 3  
Other: Sponsor request                 2  
Other: Subject ran out of medication                 1  
Other: Subject had surgery for epilepsy                 2  



  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.
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Reporting Groups
  Description
Lacosamide Up to 800 mg/day lacosamide (flexible dosing)

Baseline Measures
    Lacosamide  
Number of Participants  
[units: participants]
  308  
Age  
[units: participants]
 
<=18 years     6  
Between 18 and 65 years     295  
>=65 years     7  
Age  
[units: years]
Mean ± Standard Deviation
  38.2  ± 12.46  
Gender  
[units: participants]
 
Female     146  
Male     162  
Region of Enrollment  
[units: participants]
 
United States     308  



  Outcome Measures
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1.  Primary:   Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)   [ Time Frame: During the Treatment period (maximum 6 years) ]

2.  Primary:   Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)   [ Time Frame: During the Treatment period (maximum 6 years) ]

3.  Primary:   Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 6 Years)   [ Time Frame: During the Treatment Period (maximum 6 years) ]

4.  Secondary:   Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years)   [ Time Frame: Baseline, Treatment period (maximum 6 years) ]

5.  Secondary:   Percentage of at Least 50% Responders During the Treatment Period (Maximum 6 Years)   [ Time Frame: Treatment period (maximum 6 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 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.


Results Point of Contact:  
Name/Title: UCB (Study Director)
Organization: UCB Clinical Trial Call Center
phone: +1 887 822 9493


Publications of Results:

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00522275     History of Changes
Other Study ID Numbers: SP756
Study First Received: August 27, 2007
Results First Received: October 28, 2010
Last Updated: February 8, 2013
Health Authority: United States: Food and Drug Administration