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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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).

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of 100mg/Day and 300mg/Day Lacosamide for Migraine Prophylaxis.

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Drug: Lacosamide
* Other: Placebo
* Drug: Lacosamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of migraines headaches for 1 year and well documented 3 month retrospective history of migraines. Experience 2-8 migraines per month but not more than 15 headache days per month. There should be at least 48 hours of freedom between headaches. On effective stable abortive medication(s) for the acute treatment of migraine. Exclusion Criteria: Subject in another investigational drug or device study within the last 30 days or is currently in another investigational drug trial. Use of triptans or ergots for migraine abortive treatment > 2-3 days per calendar week 2 months prior to screening. Experience 15 or more headache days per month of any kind 2 months prior to screening. Has another consistent or chronic form of headache. Unable to stop medications, herbs, vitamins, or minerals used to prevent a migraine from occurring. Pregnant or nursing women and those of child bearing potential who are not surgically sterile, or 2 years post menopausal, or do not practice 2 combined methods of birth control, unless sexually abstinent, during the trial. Significant laboratory or electrocardiograms (ECG) abnormalities Significant medical history including cardiovascular abnormalities.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Other: Placebo<br>* Immediate-release film coated tablet (white, oval), oral administration twice daily 12 hours apart<br>|
| Experimental: Lacosamide 100mg<br>100mg lacosamide | Drug: Lacosamide<br>* Lacosamide 100mg immediate-release film-coated tablet (white,oval) oral administration twice daily 12 hours apart<br>* Other names: Vimpat;|
| Experimental: Lacosamide 300mg<br>300mg lacosamide | Drug: Lacosamide<br>* Lacosamide 300mg, immediate-release film coated tablet (white,oval), oral administration twice daily 12 hours apart.<br>* Other names: Vimpat;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lacosamide, migraine prophylaxis, Vimpat