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A Study Designed to Test the Effectiveness and Safety of Treating Patients With Lacosamide for Migraine Prophylaxis (SP906)

This study has been completed.
Information provided by (Responsible Party):
UCB Pharma Identifier:
First received: February 23, 2007
Last updated: September 19, 2014
Last verified: September 2011
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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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:

Further study details as provided by UCB Pharma:

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 ]

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 ]
  • 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 ]
  • 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 ]
  • 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 ]
    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.

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

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).

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00440518

  Hide Study Locations
United States, Alabama
Huntsville, Alabama, United States, 35801
United States, Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
Walnut Creek, California, United States
United States, Colorado
Boulder, Colorado, United States, 80304
United States, Florida
Palm Beach Gardens, Florida, United States, 33410
South Miami, Florida, United States, 33143
Sunrise, Florida, United States, 33351
United States, Georgia
Conyers, Georgia, United States, 30094
United States, Indiana
Evansville, Indiana, United States
United States, Massachusetts
Wellesley Hills, Massachusetts, United States, 02481
Worcester, Massachusetts, United States, 01605
United States, Michigan
Ann Arbor, Michigan, United States, 48104
United States, Missouri
Springfield, Missouri, United States, 65807
St. Louis, Missouri, United States, 63141
United States, New York
Albany, New York, United States, 12205
United States, North Carolina
Greensboro, North Carolina, United States, 27401
Matthews, North Carolina, United States, 28105
United States, Ohio
Cleveland, Ohio, United States, 44121
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Texas
Houston, Texas, United States, 77004
San Antonio, Texas, United States, 78258
United States, Virginia
Alexandria, Virginia, United States
United States, Washington
Seattle, Washington, United States, 98122
Sponsors and Collaborators
UCB Pharma
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
Responsible Party: UCB Pharma Identifier: NCT00440518     History of Changes
Other Study ID Numbers: SP0906
Study First Received: February 23, 2007
Results First Received: August 3, 2009
Last Updated: September 19, 2014

Keywords provided by UCB Pharma:
migraine prophylaxis

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anticonvulsants processed this record on August 16, 2017