Open-Label Study to Assess Lacosamide Safety as Add-on Therapy for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT01118949
First received: May 5, 2010
Last updated: August 8, 2012
Last verified: August 2012
Results First Received: August 8, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   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
Safety Set (SS) includes all enrolled subjects who took at least 1 dose of Lacosamide (LCM).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participant Flow and Baseline Characteristics refer to the Safety Set (SS).

Reporting Groups
  Description
Lacosamide Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.

Participant Flow:   Overall Study
    Lacosamide  
STARTED     49  
COMPLETED     40  
NOT COMPLETED     9  
Adverse Event                 5  
Withdrawal by Subject                 4  



  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 Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.

Baseline Measures
    Lacosamide  
Number of Participants  
[units: participants]
  49  
Age  
[units: participants]
 
<=18 years     3  
Between 18 and 65 years     46  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  29.7  ± 10.1  
Gender  
[units: participants]
 
Female     36  
Male     13  
Height  
[units: centimeter¬†(cm)]
Mean ± Standard Deviation
  168.08  ± 9.32  
Weight  
[units: kilogram¬†(kg)]
Mean ± Standard Deviation
  77.90  ± 19.80  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in the Number of Seizure Days With Absence Seizures From the Baseline Phase to the Maintenance Phase   [ Time Frame: From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13) ]

2.  Primary:   Change in the Number of Seizure Days With Myoclonic Seizures From the Baseline Phase to the Maintenance Phase   [ Time Frame: From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13) ]

3.  Secondary:   Changes in Count of Generalized Spike-wave Discharges on 24-hour Ambulatory Electroencephalogram (EEG) From Visit 2 (Baseline Phase) to Visit 6 (Maintenance Phase)   [ Time Frame: From Visit 2 (Week 4) to Visit 6 (Week 8) ]

4.  Secondary:   Changes in Count of 3 Hertz (Hz) Spike-wave Discharges (During Waking Hours) on 24-hour Ambulatory Electroencephalogram (EEG) From Visit 2 (Baseline Phase) to Visit 6 (Maintenance Phase)   [ Time Frame: From Visit 2 (Week 4) to Visit 6 (Week 8) ]

5.  Secondary:   Number of Subjects With Treatment Emergent Adverse Events (TEAEs) During the 10-week Treatment Period   [ Time Frame: From Visit 2 (Week 4) to Visit 7 (Week 13) ]

6.  Secondary:   Number of Subjects Withdrawn From the Study Due to Treatment Emergent Adverse Events (TEAEs) During the 10-week Treatment Period   [ Time Frame: From Visit 2 (Week 4) to Visit 7 (Week 13) ]


  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
phone: +1 877 822 9493


No publications provided


Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01118949     History of Changes
Other Study ID Numbers: SP0961
Study First Received: May 5, 2010
Results First Received: August 8, 2012
Last Updated: August 8, 2012
Health Authority: United States: Food and Drug Administration