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The purpose of this study is to see how safe and effective Lacosamide (LCM) is when taken by mouth, twice a day for up to 18 weeks to prevent migraines.
This study is for subjects who have been diagnosed with migraine for at least one year and who are currently taking an effective abortive medication(s).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| Lacosamide 100mg | Experimental | 100mg lacosamide |
|
| Lacosamide 300mg | Experimental | 300mg lacosamide |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacosamide | Drug | Lacosamide 100mg immediate-release film-coated tablet (white,oval) oral administration twice daily 12 hours apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Migraine Headache Rates During the Entire 14-week Maintenance Period | Baseline, Entire 14-week Maintenance Period |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Migraine Headache Rates During the Last 4 Weeks of the Maintenance Period | Baseline, last 4 weeks of the 14-week Maintenance Period | |
| Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Entire 14-week Maintenance Period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville | Alabama | 35801 | United States | |||
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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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.
A multicenter trial with 24 sites with enrolled subjects and 23 sites with randomized subjects from 15 Feb 2007 to 17 Jul 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart |
| FG001 | Lacosamide 100mg | Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Randomized /Titration Period |
|
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| Placebo | Other | Immediate-release film coated tablet (white, oval), oral administration twice daily 12 hours apart |
|
| Lacosamide | Drug | Lacosamide 300mg, immediate-release film coated tablet (white,oval), oral administration twice daily 12 hours apart. |
|
|
| Baseline, Entire 14-week Maintenance Period |
| 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. | Baseline, last 4 weeks of the 14-week Maintenance Period |
| Changes From Baseline in Improvement of Function and Reduction of Disability Using the Headache Impact Test (HIT-6) | 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. | Baseline, last visit in the 17-week Trial Period |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Walnut Creek | California | United States |
| Boulder | Colorado | 80304 | United States |
| Palm Beach Gardens | Florida | 33410 | United States |
| South Miami | Florida | 33143 | United States |
| Sunrise | Florida | 33351 | United States |
| Conyers | Georgia | 30094 | United States |
| Evansville | Indiana | United States |
| Wellesley Hills | Massachusetts | 02481 | United States |
| Worcester | Massachusetts | 01605 | United States |
| Ann Arbor | Michigan | 48104 | United States |
| Springfield | Missouri | 65807 | United States |
| St Louis | Missouri | 63141 | United States |
| Albany | New York | 12205 | United States |
| Greensboro | North Carolina | 27401 | United States |
| Matthews | North Carolina | 28105 | United States |
| Cleveland | Ohio | 44121 | United States |
| Oklahoma City | Oklahoma | United States |
| Nashville | Tennessee | 37203 | United States |
| Houston | Texas | 77004 | United States |
| San Antonio | Texas | 78258 | United States |
| Alexandria | Virginia | United States |
| Seattle | Washington | 98122 | United States |
| FG002 | Lacosamide 300mg | Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart |
| COMPLETED |
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| NOT COMPLETED |
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| Maintenance and Safety Follow-up Periods |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart |
| BG001 | Lacosamide 100mg | Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart |
| BG002 | Lacosamide 300mg | Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Mean Migraine Headache Rates During the Entire 14-week Maintenance Period | 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. | Posted | Mean | Standard Deviation | Number of migraine headaches | Baseline, Entire 14-week Maintenance Period |
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| Secondary | Change From Baseline in Mean Migraine Headache Rates During the Last 4 Weeks of the Maintenance Period | 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. | Posted | Mean | Standard Deviation | Number of migraine headaches | Baseline, last 4 weeks of the 14-week Maintenance Period |
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| Secondary | Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Entire 14-week Maintenance Period. | 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. | Posted | Number | Participants | Baseline, Entire 14-week Maintenance Period |
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| 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. | 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. | Posted | Number | Participants | Baseline, last 4 weeks of the 14-week Maintenance Period |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Changes From Baseline in Improvement of Function and Reduction of Disability Using the Headache Impact Test (HIT-6) | 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. | 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. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, last visit in the 17-week Trial Period |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart | 3 | 72 | 30 | 72 | ||
| EG001 | Lacosamide 100mg | Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart | 2 | 72 | 36 | 72 | ||
| EG002 | Lacosamide 300mg | Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart | 2 | 74 | 33 | 74 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery dissection | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Gallbladder disorder | Hepatobiliary disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Vaginal infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Knee operation | Surgical and medical procedures | MedDRA 11.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | UCB Clinical Trial Call Center | +1 877 822 9493 |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000078334 | Lacosamide |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Subject Withdrew Consent |
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| Unsatisfactory Compliance |
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| Other |
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| Lost to Follow-up |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Participants |
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| Participants |
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| Participants |
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