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Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures (ALEX-MT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )
ClinicalTrials.gov Identifier:
NCT00520741
First received: August 24, 2007
Last updated: July 13, 2015
Last verified: July 2015
History of Changes
Results First Received: November 26, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   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

The study was conducted at 160 sites in the United States of America (USA), Canada, Europe, and Australia.The maximum duration of a subject’s trial participation is 30 weeks.

The Participant Flow refers to the Safety Set (SS) population which consists of all patients who received at least one dose of study medication.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.

Reporting Groups
  Description
Lacosamide 300 mg/Day

Lacosamide 300 mg/day

Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.

Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.
Lacosamide 400 mg/Day

Lacosamide 400 mg/day

Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.

Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.

Participant Flow:   Overall Study
    Lacosamide 300 mg/Day     Lacosamide 400 mg/Day  
STARTED     106     319 [1]
COMPLETED     69     194  
NOT COMPLETED     37     125  
Adverse Event                 16                 56  
Lack of Efficacy                 11                 30  
Withdrawal by Subject                 0                 11  
Protocol Violation                 2                 15  
Unsatisfactory compliance of subject                 4                 3  
Lost to Follow-up                 4                 4  
Other reasons for premature termination                 0                 6  
[1] One subject was randomized at 2 sites and excluded from the Safety Set.



  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 the unique randomized subjects who took at least one dose of study medication.

Reporting Groups
  Description
Lacosamide 300 mg/Day

Lacosamide 300 mg/day

Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.

Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.
Lacosamide 400 mg/Day

Lacosamide 400 mg/day

Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.

Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.
Total Total of all reporting groups

Baseline Measures
    Lacosamide 300 mg/Day     Lacosamide 400 mg/Day     Total  
Number of Participants  
[units: participants]
 		  106     319     425  
Age  
[units: participants]
 		     
<=18 years     3     7     10  
Between 18 and 65 years     99     303     402  
>=65 years     4     9     13  
Age  
[units: years]
Mean (Standard Deviation) 		  41.4  (14.3)     40.4  (12.5)     40.6  (13.0)  
Gender  
[units: participants]
 		     
Female     50     169     219  
Male     56     150     206  
Race/Ethnicity, Customized  
[units: participants]
 		     
White     91     246     337  
Black     9     53     62  
Asian     0     1     1  
Other     6     19     25  
Height  
[units: centimeter]
Mean (Standard Deviation) 		  169.72  (10.69)     169.01  (10.87)     169.19  (10.82)  
Weight  
[units: kilogram]
Mean (Standard Deviation) 		  81.62  (19.53)     82.13  (21.30)     82.00  (20.85)  
Body Mass Index (BMI)  
[units: kg/m^2]
Mean (Standard Deviation) 		  28.22  (5.74)     28.67  (6.64)     28.56  (6.42)  
Average Baseline Seizure Frequency per 28 days  
[units: seizures/28 days]
Mean (Standard Deviation) 		  10.10  (8.82)     10.22  (8.88)     10.19  (8.86)  



  Outcome Measures
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1.  Primary:   Percentage of Subjects (Using Kaplan-Meier) Who Are Identified As Meeting At Least 1 Pre-defined Exit Criteria By Day 112 Relative To The Start of Withdrawal of Background Antiepileptic Drug(s)   [ Time Frame: 16 Weeks Maintenance Period (approximately 112 days) ]
  Show Outcome Measure 1

2.  Secondary:   Time to First Occurrence of Any Exit Event During The Maintenance Period   [ Time Frame: 16 Weeks Maintenance Period (approximately 112 days) ]
  Show Outcome Measure 2

3.  Secondary:   Percentage of Subjects (Using Kaplan-Meier) Who Are Identified as Meeting at Least 1 Pre-defined Exit Criteria by Day 112, Withdrew Due to Adverse Event (AE) or Withdrew Due to Lack of Efficacy During The Maintenance Period   [ Time Frame: 16 Weeks Maintenance Period (approximately 112 days) ]
  Show Outcome Measure 3

4.  Secondary:   Duration of Monotherapy Treatment During the Monotherapy Phase of The Maintenance Period (Visit 9 - Visit 12)   [ Time Frame: Visit 9 - Visit 12 (approximately 10 weeks) ]
  Show Outcome Measure 4

5.  Secondary:   Clinical Global Impression of Change (CGIC) From Baseline To Last Visit   [ Time Frame: Baseline; Last Visit (approximately 27 weeks) ]
  Show Outcome Measure 5

6.  Secondary:   Patient's Global Impression of Change (PGIC) From Baseline To Last Visit   [ Time Frame: Baseline; Last Visit (approximately 27 weeks) ]
  Show Outcome Measure 6


  Serious Adverse Events
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  Other Adverse Events
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  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: UCB Pharma ( UCB BIOSCIENCES, Inc. )
ClinicalTrials.gov Identifier: NCT00520741     History of Changes
Obsolete Identifiers: NCT01058954
Other Study ID Numbers: SP0902
2007-005439-27 ( EudraCT Number )
Study First Received: August 24, 2007
Results First Received: November 26, 2013
Last Updated: July 13, 2015
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Spain: Spanish Agency of Medicines
Denmark: Danish Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration
Italy: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices