- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00440518
A Study Designed to Test the Effectiveness and Safety of Treating Patients With Lacosamide for Migraine Prophylaxis (SP906)
June 20, 2018 updated by: UCB Pharma
A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of 100mg/Day and 300mg/Day Lacosamide for Migraine Prophylaxis.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
218
Phase
- Phase 2
Expanded Access
No longer available outside the clinical trial.
See expanded access record.
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Huntsville, Alabama, United States, 35801
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Arkansas
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Little Rock, Arkansas, United States, 72205
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California
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Walnut Creek, California, United States
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Colorado
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Boulder, Colorado, United States, 80304
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Florida
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Palm Beach Gardens, Florida, United States, 33410
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South Miami, Florida, United States, 33143
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Sunrise, Florida, United States, 33351
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Georgia
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Conyers, Georgia, United States, 30094
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Indiana
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Evansville, Indiana, United States
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Massachusetts
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Wellesley Hills, Massachusetts, United States, 02481
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Worcester, Massachusetts, United States, 01605
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Michigan
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Ann Arbor, Michigan, United States, 48104
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Missouri
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Saint Louis, Missouri, United States, 63141
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Springfield, Missouri, United States, 65807
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New York
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Albany, New York, United States, 12205
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North Carolina
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Greensboro, North Carolina, United States, 27401
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Matthews, North Carolina, United States, 28105
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Ohio
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Cleveland, Ohio, United States, 44121
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Oklahoma
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Oklahoma City, Oklahoma, United States
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Tennessee
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Nashville, Tennessee, United States, 37203
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Texas
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Houston, Texas, United States, 77004
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San Antonio, Texas, United States, 78258
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Virginia
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Alexandria, Virginia, United States
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Washington
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Seattle, Washington, United States, 98122
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
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Immediate-release film coated tablet (white, oval), oral administration twice daily 12 hours apart
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Experimental: Lacosamide 100mg
100mg lacosamide
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Lacosamide 100mg immediate-release film-coated tablet (white,oval) oral administration twice daily 12 hours apart
Other Names:
Lacosamide 300mg, immediate-release film coated tablet (white,oval), oral administration twice daily 12 hours apart.
Other Names:
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Experimental: Lacosamide 300mg
300mg lacosamide
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Lacosamide 100mg immediate-release film-coated tablet (white,oval) oral administration twice daily 12 hours apart
Other Names:
Lacosamide 300mg, immediate-release film coated tablet (white,oval), oral administration twice daily 12 hours apart.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change From Baseline in Mean Migraine Headache Rates During the Entire 14-week Maintenance Period
Time Frame: Baseline, Entire 14-week Maintenance Period
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Baseline, Entire 14-week Maintenance Period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Baseline, last 4 weeks of the 14-week Maintenance Period
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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
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Baseline, Entire 14-week Maintenance Period
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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
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Baseline, last 4 weeks of the 14-week Maintenance Period
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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
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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.
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Baseline, last visit in the 17-week Trial Period
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
February 23, 2007
First Submitted That Met QC Criteria
February 26, 2007
First Posted (Estimate)
February 27, 2007
Study Record Updates
Last Update Posted (Actual)
July 17, 2018
Last Update Submitted That Met QC Criteria
June 20, 2018
Last Verified
July 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Headache Disorders, Primary
- Headache Disorders
- Migraine Disorders
- Molecular Mechanisms of Pharmacological Action
- Membrane Transport Modulators
- Anticonvulsants
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lacosamide
Other Study ID Numbers
- SP0906
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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