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

UCB Pharma0 sites218 target enrollmentFebruary 2007

ConditionsMigraine

InterventionsPlacebo Lacosamide

DrugsLacosamide

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Migraine
Sponsor: UCB Pharma
Enrollment: 218
Primary Endpoint: Change From Baseline in Mean Migraine Headache Rates During the Entire 14-week Maintenance Period
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

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).

Registry

clinicaltrials.gov

Start Date

February 2007

End Date

July 2008

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

UCB Pharma

Responsible Party

Sponsor

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.

Arms & Interventions

Placebo

Intervention: Placebo

Lacosamide 100mg

100mg lacosamide

Intervention: Lacosamide

Lacosamide 300mg

300mg lacosamide

Intervention: Lacosamide

Outcomes

Primary Outcomes

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

Time Frame: Baseline, Entire 14-week Maintenance Period

Secondary Outcomes

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)
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)