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Trial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00955357
First received: August 6, 2009
Last updated: October 17, 2014
Last verified: June 2014
Results First Received: March 28, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel 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
An estimated 656 subjects were to be enrolled in the study at approximately 130 sites in the US, Europe, and the rest of the world.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Overall 461 subjects were enrolled. The Participant Flow refers to the Safety Set (SS) which was defined as all enrolled subjects who took at least 1 dose of Lacosamide. Reasons for discontinuation were only calculated for the SS. 456 subjects were included in the Safety Set.

Reporting Groups
  Description
First Add-on

Lacosamide added to first adequate monotherapy (no history of Anti-Epileptic Drug [AED] polytherapy) and epilepsy diagnosis < or = 24 months at Screening.

Lacosamide: oral tablet

Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid

Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid

Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week

Later Add-on

Lacosamide added to 1 to 3 Anti-Epileptic Drugs (AEDs) (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis > or = 5 years at Screening.

Lacosamide: oral tablet

Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid

Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid

Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week


Participant Flow for 2 periods

Period 1:   Titration Phase
    First Add-on   Later Add-on
STARTED   96   360 
COMPLETED   80   294 
NOT COMPLETED   16   66 
Adverse Event                9                46 
Lack of Efficacy                0                2 
Protocol Violation                3                7 
Lost to Follow-up                1                3 
Withdrawal by Subject                3                5 
Prohibited Antiepileptic Drug change                0                1 
Study medication not tolerated                0                1 
Non compliance to study procedures                0                1 

Period 2:   Maintenance Phase
    First Add-on   Later Add-on
STARTED   80   294 
COMPLETED   68   249 
NOT COMPLETED   12   45 
Adverse Event                3                23 
Lack of Efficacy                0                4 
Protocol Violation                2                6 
Lost to Follow-up                2                7 
Withdrawal by Subject                4                4 
Patient moving out of area                0                1 
Non compliance to study procedures                1                0 



  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.
The Baseline Analysis Population refers to the Safety Set (SS) which includes all enrolled subjects who took at least one dose of study medication. 5 subjects at one site were excluded from the Safety Set due to significant study conduct deficiencies.

Reporting Groups
  Description
First Add-on

Lacosamide added to first adequate monotherapy (no history of AED polytherapy) and epilepsy diagnosis < or = 24 months at Screening.

Lacosamide: oral tablet

Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid

Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid

Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week

Later-Add-on

Lacosamide added to 1 to 3 AEDs (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis > or = 5 years at Screening.

Lacosamide: oral tablet

Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid

Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid

Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week

Total Total of all reporting groups

Baseline Measures
   First Add-on   Later-Add-on   Total 
Overall Participants Analyzed 
[Units: Participants]
 96   360   456 
Age 
[Units: Years]
Median (Full Range)
 37.5 
 (18.0 to 82.0) 
 38.0 
 (16.0 to 74.0) 
 38.0 
 (16.0 to 82.0) 
Age 
[Units: Participants]
     
<=18 years   4   7   11 
Between 18 and 65 years   82   349   431 
>=65 years   10   4   14 
Gender 
[Units: Participants]
     
Female   53   180   233 
Male   43   180   223 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   11   6   17 
Asian   0   12   12 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   1   19   20 
White   79   278   357 
More than one race   5   45   50 
Unknown or Not Reported   0   0   0 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   24   99   123 
Not Hispanic or Latino   72   261   333 
Unknown or Not Reported   0   0   0 
Weight 
[Units: Kilogram]
Median (Full Range)
 71.8 
 (42.0 to 132.9) 
 73.0 
 (41.9 to 147.4) 
 73.0 
 (41.9 to 147.4) 
Height 
[Units: Centimeter]
Median (Full Range)
 166.5 
 (149.0 to 186.0) 
 167.6 
 (140.0 to 197.0) 
 167.6 
 (140.0 to 197.0) 
BMI 
[Units: Kilogram per m^2]
Median (Full Range)
 25.3 
 (14.5 to 42.5) 
 25.5 
 (17.3 to 53.9) 
 25.4 
 (14.5 to 53.9) 


  Outcome Measures

1.  Primary:   The Proportion of Subjects Who Achieved "Seizure-free Status" During the First 12 Weeks of the Maintenance Phase   [ Time Frame: From Week 7 (end of Week 6) to end of Week 18 ]


  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
This study was intended to assess the efficacy outcomes in the First Add-On Group and the Later Add-On Group individually relative to historical data. Comparisons between the 2 groups should not be attempted and conclusions should not be drawn.


  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



Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00955357     History of Changes
Other Study ID Numbers: SP0954
2009-011181-28 ( EudraCT Number )
Study First Received: August 6, 2009
Results First Received: March 28, 2014
Last Updated: October 17, 2014
Health Authority: United States: Food and Drug Administration
Austria: Agency for Health and Food Safety
Bulgaria: Bulgarian Drug Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Greece: National Organization of Medicines
Italy: The Italian Medicines Agency
Mexico: Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Spain: Ministry of Health
Switzerland: Swissmedic
Turkey: Ministry of Health