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

Phase 2

Completed

• Conditions: Migraine
• Interventions: Other: Placebo; Drug: Lacosamide

• Registration Number: NCT00440518
• Lead Sponsor: UCB Pharma

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).

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-02-23
• Study First Submitted QC: 2007-02-26
• Study First Posted: 2007-02-27
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Results First Submitted: 2009-08-03
• Results First Submitted QC: 2009-08-03
• Results First Posted: 2009-09-11
• Status Verified: 2017-07
• Last Update Submitted: 2018-06-20
• Last Update Posted: 2018-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Lacosamide 300mg	Lacosamide	300mg lacosamide
Lacosamide 100mg	Lacosamide	100mg lacosamide

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Migraine Headache Rates During the Entire 14-week Maintenance Period	Baseline, Entire 14-week Maintenance Period

Secondary Outcome Measures

Name	Time	Method
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 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)	Baseline, last visit in the 17-week Trial Period	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.
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