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Trial record 1 of 1 for:    NCT00440518
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A Study Designed to Test the Effectiveness and Safety of Treating Patients With Lacosamide for Migraine Prophylaxis (SP906)

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ClinicalTrials.gov Identifier: NCT00440518
Recruitment Status : Completed
First Posted : February 27, 2007
Results First Posted : September 11, 2009
Last Update Posted : July 17, 2018
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Migraine Drug: Lacosamide Other: Placebo Phase 2

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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.
Study Start Date : February 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine
Drug Information available for: Lacosamide

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00440518

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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
Saint Louis, Missouri, United States, 63141
Springfield, Missouri, United States, 65807
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
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Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
Additional Information:
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Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00440518    
Other Study ID Numbers: SP0906
First Posted: February 27, 2007    Key Record Dates
Results First Posted: September 11, 2009
Last Update Posted: July 17, 2018
Last Verified: July 2017
Keywords provided by UCB Pharma:
migraine prophylaxis
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action