Clinical trial NCT00440518: A Study Designed to Test the Effectiveness and Safety of Treating Patients With Lacosamide for Migraine Prophylaxis
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine
Keywords: Lacosamide
migraine prophylaxis
Vimpat
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-02-27
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Change From Baseline in Mean Migraine Headache Rates During the Entire 14-week Maintenance Period
timeFrame: Baseline, Entire 14-week Maintenance Period
Secondary outcomes:
measure: Change From Baseline in Mean Migraine Headache Rates During the Last 4 Weeks of the Maintenance Period
timeFrame: Baseline, last 4 weeks of the 14-week Maintenance Period
measure: Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Entire 14-week Maintenance Period.
timeFrame: Baseline, Entire 14-week Maintenance Period
measure: 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.
timeFrame: Baseline, last 4 weeks of the 14-week Maintenance Period
measure: Changes From Baseline in Improvement of Function and Reduction of Disability Using the Headache Impact Test (HIT-6)
timeFrame: Baseline, last visit in the 17-week Trial Period
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Little Rock
country: United States
state: Arkansas
city: Walnut Creek
country: United States
state: California
city: Boulder
country: United States
state: Colorado
city: Palm Beach Gardens
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: Sunrise
country: United States
state: Florida
city: Conyers
country: United States
state: Georgia
city: Evansville
country: United States
state: Indiana
city: Wellesley Hills
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Saint Louis
country: United States
state: Missouri
city: Springfield
country: United States
state: Missouri
city: Albany
country: United States
state: New York
city: Greensboro
country: United States
state: North Carolina
city: Matthews
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Alexandria
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: