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Trial record 1 of 1 for:    NCT00440518
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A Study Designed to Test the Effectiveness and Safety of Treating Patients With Lacosamide for Migraine Prophylaxis (SP906)

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ClinicalTrials.gov Identifier: NCT00440518
Recruitment Status : Completed
First Posted : February 27, 2007
Results First Posted : September 11, 2009
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Migraine
Interventions Drug: Lacosamide
Other: Placebo
Enrollment 218
Recruitment Details 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 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.
Arm/Group Title Placebo Lacosamide 100mg Lacosamide 300mg
Hide Arm/Group Description Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
Period Title: Randomized /Titration Period
Started 72 72 74
Completed 59 63 70
Not Completed 13 9 4
Reason Not Completed
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 Title: Maintenance and Safety Follow-up Periods
Started 59 63 70
Completed 52 51 55
Not Completed 7 12 15
Reason Not Completed
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
Arm/Group Title Placebo Lacosamide 100mg Lacosamide 300mg Total
Hide Arm/Group Description Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart Total of all reporting groups
Overall Number of Baseline Participants 72 72 74 218
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 72 participants 74 participants 218 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
72
 100.0%
72
 100.0%
74
 100.0%
218
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 72 participants 72 participants 74 participants 218 participants
39.3  (12.23) 40.1  (11.86) 40.2  (11.40) 39.9  (11.78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 72 participants 74 participants 218 participants
Female
62
  86.1%
62
  86.1%
63
  85.1%
187
  85.8%
Male
10
  13.9%
10
  13.9%
11
  14.9%
31
  14.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 72 participants 72 participants 74 participants 218 participants
72 72 74 218
1.Primary Outcome
Title Change From Baseline in Mean Migraine Headache Rates During the Entire 14-week Maintenance Period
Hide Description [Not Specified]
Time Frame Baseline, Entire 14-week Maintenance Period
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Lacosamide 100mg Lacosamide 300mg
Hide Arm/Group Description:
Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
Overall Number of Participants Analyzed 71 70 74
Mean (Standard Deviation)
Unit of Measure: Number of migraine headaches
-1.4  (3.12) -1.4  (2.68) -1.6  (2.10)
2.Secondary Outcome
Title Change From Baseline in Mean Migraine Headache Rates During the Last 4 Weeks of the Maintenance Period
Hide Description [Not Specified]
Time Frame Baseline, last 4 weeks of the 14-week Maintenance Period
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Lacosamide 100mg Lacosamide 300mg
Hide Arm/Group Description:
Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
Overall Number of Participants Analyzed 71 70 74
Mean (Standard Deviation)
Unit of Measure: Number of migraine headaches
-1.3  (3.45) -1.3  (2.82) -1.7  (2.44)
3.Secondary Outcome
Title Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Entire 14-week Maintenance Period.
Hide Description [Not Specified]
Time Frame Baseline, Entire 14-week Maintenance Period
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Lacosamide 100mg Lacosamide 300mg
Hide Arm/Group Description:
Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
Overall Number of Participants Analyzed 71 70 74
Measure Type: Number
Unit of Measure: Participants
26 32 29
4.Secondary Outcome
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.
Hide Description [Not Specified]
Time Frame Baseline, last 4 weeks of the 14-week Maintenance Period
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Lacosamide 100mg Lacosamide 300mg
Hide Arm/Group Description:
Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
Overall Number of Participants Analyzed 71 70 74
Measure Type: Number
Unit of Measure: Participants
27 27 33
5.Secondary Outcome
Title Changes From Baseline in Improvement of Function and Reduction of Disability Using the Headache Impact Test (HIT-6)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Lacosamide 100mg Lacosamide 300mg
Hide Arm/Group Description:
Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
Overall Number of Participants Analyzed 64 66 66
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-3.8  (7.78) -4.3  (8.67) -3.5  (8.03)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Lacosamide 100mg Lacosamide 300mg
Hide Arm/Group Description Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
All-Cause Mortality
Placebo Lacosamide 100mg Lacosamide 300mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo Lacosamide 100mg Lacosamide 300mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/72 (4.17%)      2/72 (2.78%)      2/74 (2.70%)    
Cardiac disorders       
Coronary artery dissection * 1  0/72 (0.00%)  0 0/72 (0.00%)  0 1/74 (1.35%)  1
Myocardial infarction * 1  0/72 (0.00%)  0 1/72 (1.39%)  1 0/74 (0.00%)  0
Hepatobiliary disorders       
Gallbladder disorder * 1  1/72 (1.39%)  1 0/72 (0.00%)  0 0/74 (0.00%)  0
Infections and infestations       
Vaginal infection * 1  0/72 (0.00%)  0 0/72 (0.00%)  0 1/74 (1.35%)  2
Viral infection * 1  1/72 (1.39%)  1 0/72 (0.00%)  0 0/74 (0.00%)  0
Nervous system disorders       
Syncope * 1  1/72 (1.39%)  1 0/72 (0.00%)  0 0/74 (0.00%)  0
Psychiatric disorders       
Depression * 1  1/72 (1.39%)  1 0/72 (0.00%)  0 0/74 (0.00%)  0
Surgical and medical procedures       
Knee operation * 1  0/72 (0.00%)  0 1/72 (1.39%)  1 0/74 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Lacosamide 100mg Lacosamide 300mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/72 (41.67%)      36/72 (50.00%)      33/74 (44.59%)    
Gastrointestinal disorders       
Diarrhoea * 1  5/72 (6.94%)  5 4/72 (5.56%)  8 4/74 (5.41%)  5
Nausea * 1  7/72 (9.72%)  9 5/72 (6.94%)  5 3/74 (4.05%)  4
Vomiting * 1  4/72 (5.56%)  4 1/72 (1.39%)  1 0/74 (0.00%)  0
General disorders       
Fatigue * 1  1/72 (1.39%)  1 5/72 (6.94%)  5 11/74 (14.86%)  12
Infections and infestations       
Nasopharyngitis * 1  7/72 (9.72%)  7 12/72 (16.67%)  12 11/74 (14.86%)  13
Influenza * 1  5/72 (6.94%)  5 3/72 (4.17%)  3 4/74 (5.41%)  4
Bronchitis * 1  0/72 (0.00%)  0 2/72 (2.78%)  2 4/74 (5.41%)  4
Sinusitis * 1  1/72 (1.39%)  1 4/72 (5.56%)  4 3/74 (4.05%)  3
Upper respiratory tract infection * 1  5/72 (6.94%)  6 7/72 (9.72%)  9 1/74 (1.35%)  1
Musculoskeletal and connective tissue disorders       
Back pain * 1  4/72 (5.56%)  4 2/72 (2.78%)  2 2/74 (2.70%)  2
Nervous system disorders       
Dizziness * 1  4/72 (5.56%)  6 5/72 (6.94%)  6 2/74 (2.70%)  4
Headache * 1  5/72 (6.94%)  11 3/72 (4.17%)  9 2/74 (2.70%)  4
Respiratory, thoracic and mediastinal disorders       
Oropharyngeal pain * 1  2/72 (2.78%)  2 3/72 (4.17%)  3 4/74 (5.41%)  4
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.1
[Not Specified]
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.
UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: UCB Clinical Trial Call Center
Phone: +1 877 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00440518    
Other Study ID Numbers: SP0906
First Submitted: February 23, 2007
First Posted: February 27, 2007
Results First Submitted: August 3, 2009
Results First Posted: September 11, 2009
Last Update Posted: July 17, 2018