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

Sponsor:	UCB, Inc.
Information provided by:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00440518

Purpose

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.

Condition	Intervention	Phase
Migraine	Drug: Lacosamide Other: Placebo	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

Change From Baseline in Mean Migraine Headache Rates During the Entire 14-week Maintenance Period [ Time Frame: Baseline, Entire 14-week Maintenance Period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change From Baseline in Mean Migraine Headache Rates During the Last 4 Weeks of the Maintenance Period [ Time Frame: Baseline, last 4 weeks of the 14-week Maintenance Period ] [ Designated as safety issue: No ]
Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Entire 14-week Maintenance Period. [ Time Frame: Baseline, Entire 14-week Maintenance Period ] [ Designated as safety issue: No ]
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. [ Time Frame: Baseline, last 4 weeks of the 14-week Maintenance Period ] [ Designated as safety issue: No ]
Changes From Baseline in Improvement of Function and Reduction of Disability Using the Headache Impact Test (HIT-6) [ Time Frame: Baseline, last visit in the 17-week Trial Period ] [ Designated as safety issue: No ]

Enrollment:	218
Study Start Date:	February 2007
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator Placebo	Other: Placebo Immediate-release film coated tablet (white, oval), oral administration twice daily 12 hours apart
Lacosamide 100mg: Experimental 100mg lacosamide	Drug: Lacosamide Lacosamide 100mg immediate-release film-coated tablet (white,oval) oral administration twice daily 12 hours apart
Lacosamide 300mg: Experimental 300mg lacosamide	Drug: Lacosamide Lacosamide 300mg, immediate-release film coated tablet (white,oval), oral administration twice daily 12 hours apart.

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440518

Show 24 Study Locations

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

Additional Information:

FDA Safety Alerts and Recalls This link exits the ClinicalTrials.gov site

Product Information This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	SP906
Study First Received:	February 23, 2007
Results First Received:	August 3, 2009
Last Updated:	December 23, 2009
ClinicalTrials.gov Identifier:	NCT00440518 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by UCB, Inc.:

Lacosamide
migraine prophylaxis
Vimpat

Additional relevant MeSH terms:

Migraine Disorders
Nervous System Diseases
Central Nervous System Diseases

Headache Disorders, Primary
Brain Diseases
Headache Disorders

ClinicalTrials.gov processed this record on February 08, 2010