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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;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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  
Number of Participants  
[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
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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 ]
  Show Outcome Measure 1

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 ]
  Show Outcome Measure 2

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 ]
  Show Outcome Measure 3

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 ]
  Show Outcome Measure 4

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 ]
  Show Outcome Measure 5


  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
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
Health Authority: United States: Food and Drug Administration