Trial record 1 of 1 for:    NCT00552305
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To Determine Tolerability 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:
NCT00552305
First received: October 30, 2007
Last updated: September 19, 2014
Last verified: September 2011
Results First Received: February 23, 2011  
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
The study was started in August of 2001 with recruitment occurring in the United States, Germany, Hungary, Lithuania, Poland, Sweden, Switzerland, and the United Kingdom. The study had last patient last visit in February of 2010.

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 50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)

Participant Flow:   Overall Study
    Lacosamide  
STARTED     370  
COMPLETED     120  
NOT COMPLETED     250  
Adverse Event                 43  
Lack of Efficacy                 120  
Lost to Follow-up                 4  
Protocol Violation                 3  
Withdrawal by Subject                 44  
Lack of efficacy/withdrew consent                 1  
Lack of efficacy (LoE)/adverse event                 3  
Adverse event (AE)/withdrew (WD) consent                 2  
Unsatisfactory compliance                 11  
Poor compliance/lost to follow-up                 1  
AE/Other: prohibited drug required                 1  
LoE/WD consent/Other: cannot make visits                 1  
Other: Site closed                 4  
Other: Personal problems                 1  
Other: Unable to attend visits                 1  
Other: Subject underwent surgery                 4  
Other: Subject became pregnant                 1  
Other: Health problems, not drug related                 1  
Other: Subject moved from area                 2  
Other: Subject incarcerated                 1  
Other: Subject went to rehab                 1  



  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.
No text entered.

Reporting Groups
  Description
Lacosamide 50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)

Baseline Measures
    Lacosamide  
Number of Participants  
[units: participants]
  370  
Age  
[units: participants]
 
<=18 years     3  
Between 18 and 65 years     364  
>=65 years     3  
Age  
[units: years]
Mean ± Standard Deviation
  40.8  ± 11.01  
Gender  
[units: participants]
 
Female     192  
Male     178  
Region of Enrollment  
[units: participants]
 
United States     248  
Hungary     13  
Poland     4  
Lithuania     46  
Germany     21  
United Kingdom     12  
Switzerland     2  
Sweden     24  



  Outcome Measures
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1.  Primary:   Number of Subjects Reporting at Least 1 Treat-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years)   [ Time Frame: During the Treatment Period (up to 8 years) ]

2.  Primary:   Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years)   [ Time Frame: During the Treatment Period (up to 8 years) ]

3.  Primary:   Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 8 Years)   [ Time Frame: During the Treatment Period (up to 8 years) ]

4.  Secondary:   Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 8 Years)   [ Time Frame: Baseline, End of Treatment Period (up to 8 years) ]

5.  Secondary:   Percentage of at Least 50% Responders During the Treatment Period (up to 8 Years)   [ Time Frame: Treatment Period (up to 8 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
No text entered.


  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


No publications provided


Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00552305     History of Changes
Other Study ID Numbers: SP0615
Study First Received: October 30, 2007
Results First Received: February 23, 2011
Last Updated: September 19, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Lithuania: State Medicine Control Agency - Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency