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A Study Designed to Test the Effectiveness and Safety of Treating Patients With Lacosamide for Migraine Prophylaxis (SP906)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00440518
First received: February 23, 2007
Last updated: September 19, 2014
Last verified: September 2011
History of Changes
Results First Received: August 3, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Migraine
Interventions: Drug: Lacosamide
Other: Placebo

  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
A multicenter trial with 24 sites with enrolled subjects and 23 sites with randomized subjects from 15 Feb 2007 to 17 Jul 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects on stable dose of prophylactic medication entered a 2-week Wash-Out Period followed by a 4-week Baseline Period without any prophylactic medication. Subjects not taking prophylactic medication entered the Baseline Period directly for 6 weeks. Subjects entered a 3-week Titration Period and if completed entered a 14-week Maintenance Period.

Reporting Groups
  Description
Placebo Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
Lacosamide 100mg Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
Lacosamide 300mg Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart

Participant Flow for 2 periods

 Period 1:   Randomized /Titration Period
    Placebo   Lacosamide 100mg   Lacosamide 300mg
STARTED   72   72   74 
COMPLETED   59   63   70 
NOT COMPLETED   13   9   4 
Lack of Efficacy                1                0                1 
Subject Withdrew Consent                4                1                0 
Protocol Deviation                1                0                0 
Unsatisfactory Compliance                2                3                2 
Other                1                0                0 
Lost to Follow-up                2                2                1 
Adverse Event                2                3                0 

Period 2:   Maintenance and Safety Follow-up Periods
    Placebo   Lacosamide 100mg   Lacosamide 300mg
STARTED   59   63   70 
COMPLETED   52   51   55 
NOT COMPLETED   7   12   15 
Adverse Event                3                4                2 
Lack of Efficacy                0                1                1 
Subject Withdrew Consent                3                2                4 
Unsatisfactory Compliance                0                3                6 
Other                0                0                2 
Lost to Follow-up                1                2                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.
No text entered.

Reporting Groups
  Description
Placebo Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
Lacosamide 100mg Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
Lacosamide 300mg Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
Total Total of all reporting groups

Baseline Measures
   Placebo   Lacosamide 100mg   Lacosamide 300mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 72   72   74   218 
Age 
[Units: Participants]
 		       
<=18 years   0   0   0   0 
Between 18 and 65 years   72   72   74   218 
>=65 years   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation) 		 39.3  (12.23)   40.1  (11.86)   40.2  (11.40)   39.9  (11.78) 
Gender 
[Units: Participants]
 		       
Female   62   62   63   187 
Male   10   10   11   31 
Region of Enrollment 
[Units: Participants]
 		       
United States   72   72   74   218 


  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Change From Baseline in Mean Migraine Headache Rates During the Entire 14-week Maintenance Period   [ Time Frame: Baseline, Entire 14-week Maintenance Period ]

Measure Type Primary
Measure Title Change From Baseline in Mean Migraine Headache Rates During the Entire 14-week Maintenance Period
Measure Description No text entered.
Time Frame Baseline, Entire 14-week Maintenance Period  

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.
Of the 72 (Placebo), 72 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects randomized, 71, 70, and 74 subjects respectively are included in this summary based on the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value). This summary uses a Last Observation Carried Forward (LOCF) approach.

Reporting Groups
  Description
Placebo Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
Lacosamide 100mg Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
Lacosamide 300mg Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart

Measured Values
   Placebo   Lacosamide 100mg   Lacosamide 300mg 
Participants Analyzed 
[Units: Participants]
 		 71   70   74 
Change From Baseline in Mean Migraine Headache Rates During the Entire 14-week Maintenance Period 
[Units: Number of migraine headaches]
Mean (Standard Deviation) 		 -1.4  (3.12)   -1.4  (2.68)   -1.6  (2.10) 

No statistical analysis provided for Change From Baseline in Mean Migraine Headache Rates During the Entire 14-week Maintenance Period



2.  Secondary:   Change From Baseline in Mean Migraine Headache Rates During the Last 4 Weeks of the Maintenance Period   [ Time Frame: Baseline, last 4 weeks of the 14-week Maintenance Period ]

Measure Type Secondary
Measure Title Change From Baseline in Mean Migraine Headache Rates During the Last 4 Weeks of the Maintenance Period
Measure Description No text entered.
Time Frame Baseline, last 4 weeks of the 14-week Maintenance Period  

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.
Of the 72 (Placebo), 72 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects randomized, 71, 70, and 74 subjects respectively are included in this summary based on the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value). This summary uses a Last Observation Carried Forward (LOCF) approach.

Reporting Groups
  Description
Placebo Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
Lacosamide 100mg Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
Lacosamide 300mg Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart

Measured Values
   Placebo   Lacosamide 100mg   Lacosamide 300mg 
Participants Analyzed 
[Units: Participants]
 		 71   70   74 
Change From Baseline in Mean Migraine Headache Rates During the Last 4 Weeks of the Maintenance Period 
[Units: Number of migraine headaches]
Mean (Standard Deviation) 		 -1.3  (3.45)   -1.3  (2.82)   -1.7  (2.44) 

No statistical analysis provided for Change From Baseline in Mean Migraine Headache Rates During the Last 4 Weeks of the Maintenance Period



3.  Secondary:   Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Entire 14-week Maintenance Period.   [ Time Frame: Baseline, Entire 14-week Maintenance Period ]

Measure Type Secondary
Measure Title Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Entire 14-week Maintenance Period.
Measure Description No text entered.
Time Frame Baseline, Entire 14-week Maintenance Period  

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.
Of the 72 (Placebo), 72 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects randomized, 71, 70, and 74 subjects respectively are included in this summary based on the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value). This summary uses a Last Observation Carried Forward (LOCF) approach.

Reporting Groups
  Description
Placebo Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
Lacosamide 100mg Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
Lacosamide 300mg Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart

Measured Values
   Placebo   Lacosamide 100mg   Lacosamide 300mg 
Participants Analyzed 
[Units: Participants]
 		 71   70   74 
Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Entire 14-week Maintenance Period. 
[Units: Participants]
 		 26   32   29 

No statistical analysis provided for Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Entire 14-week Maintenance Period.



4.  Secondary:   Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Last 4 Weeks of the Maintenance Period.   [ Time Frame: Baseline, last 4 weeks of the 14-week Maintenance Period ]

Measure Type Secondary
Measure Title Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Last 4 Weeks of the Maintenance Period.
Measure Description No text entered.
Time Frame Baseline, last 4 weeks of the 14-week Maintenance Period  

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.
Of the 72 (Placebo), 72 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects randomized, 71, 70, and 74 subjects respectively are included in this summary based on the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value). This summary uses a Last Observation Carried Forward (LOCF) approach.

Reporting Groups
  Description
Placebo Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
Lacosamide 100mg Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
Lacosamide 300mg Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart

Measured Values
   Placebo   Lacosamide 100mg   Lacosamide 300mg 
Participants Analyzed 
[Units: Participants]
 		 71   70   74 
Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Last 4 Weeks of the Maintenance Period. 
[Units: Participants]
 		 27   27   33 

No statistical analysis provided for Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Last 4 Weeks of the Maintenance Period.



5.  Secondary:   Changes From Baseline in Improvement of Function and Reduction of Disability Using the Headache Impact Test (HIT-6)   [ Time Frame: Baseline, last visit in the 17-week Trial Period ]

Measure Type Secondary
Measure Title Changes From Baseline in Improvement of Function and Reduction of Disability Using the Headache Impact Test (HIT-6)
Measure Description Headache Impact Test (HIT-6™) consists of 6 items designed to measure the impact headaches have on a person’s ability to function. Scores from the 6 questions will be added to create a total score. Range of the total score is 36 to 78. Higher scores indicate a greater impact on the subject’s quality of life.
Time Frame Baseline, last visit in the 17-week Trial Period  

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.
Of the 71 (Placebo), 70 (Lacosamide 100mg) and 74 (Lacosamide 300mg) subjects in the Full Analysis Set (must have Baseline and at least one post-Baseline efficacy value), 64, 66, and 66 subjects respectively are included in this summary.

Reporting Groups
  Description
Placebo Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
Lacosamide 100mg Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
Lacosamide 300mg Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart

Measured Values
   Placebo   Lacosamide 100mg   Lacosamide 300mg 
Participants Analyzed 
[Units: Participants]
 		 64   66   66 
Changes From Baseline in Improvement of Function and Reduction of Disability Using the Headache Impact Test (HIT-6) 
[Units: Scores on a scale]
Mean (Standard Deviation) 		 -3.8  (7.78)   -4.3  (8.67)   -3.5  (8.03) 

No statistical analysis provided for Changes From Baseline in Improvement of Function and Reduction of Disability Using the Headache Impact Test (HIT-6)




  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
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  Limitations and Caveats
  Hide Limitations and Caveats

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: Study Director
Organization: UCB Clinical Trial Call Center
phone: +1 877 822 9493



Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00440518     History of Changes
Other Study ID Numbers: SP0906
Study First Received: February 23, 2007
Results First Received: August 3, 2009
Last Updated: September 19, 2014