Assessing Efficacy and Safety of Lacosamide Compared to Placebo in Reducing Signs and Symptoms of Fibromyalgia Syndrome.
NCT ID: NCT00401830
Last Updated: 2018-07-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
159 participants
INTERVENTIONAL
2006-10-31
2008-02-29
Brief Summary
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Detailed Description
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The trial consisted of a 4-week Titration Phase, an 8-week Maintenance Phase, a 1-week Taper Phase, and a 2-week Safety Follow-Up Phase. If subjects met the eligibility criteria, they were randomized to receive either lacosamide 400mg/day or placebo during the Maintenance Phase. Subjects assigned to lacosamide were titrated from 100mg/day to 400mg/day at weekly intervals of 100mg. All subjects who completed the 4-week Titration Phase entered an 8-week Maintenance Phase. No dose adjustment was allowed during the Maintenance Phase. The Treatment Phase was defined as the combined Titration and Maintenance Phases.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo
Matching placebo tablet administered twice daily
Lacosamide
Lacosamide Tablet 400mg daily
Lacosamide
Tablet 400mg daily (200mg twice daily) during 8-week maintenance phase following 4-week titration phase starting at 100mg/day and increasing to 400mg/day at weekly intervals of 100mg
Interventions
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Lacosamide
Tablet 400mg daily (200mg twice daily) during 8-week maintenance phase following 4-week titration phase starting at 100mg/day and increasing to 400mg/day at weekly intervals of 100mg
Placebo
Matching placebo tablet administered twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Fulfills all 3 points of American College of Rheumatology (ACR) definition for diagnosis of fibromyalgia
* At least moderate pain (pain intensity ≥ 5 on Likert pain scale (0-10) during the 7 days prior to Baseline)
* Fibromyalgia Impact Questionnaire (FIQ) total score ≥ 50
* Completed an adequate washout period for excluded medications prior to beginning the Baseline Diary Phase
Exclusion Criteria
* Diagnosed neuropathic pain syndrome
* Receiving treatment with neurostimulating devices
* Significant psychopathology
* History of chronic alcohol or drug abuse within 6 months prior to Screening
* Been hospitalized for psychiatric or behavioral reasons within 6 months prior to Screening
* Clinically significant abnormal vitals, cardiac dysfunction and /or arrhythmias
* Taken neuroleptics, serotonin and norepinephrine reuptake inhibitors (SNRIs) or tricyclic antidepressants (TCAs)
* Other medical conditions that could compromise the subject's ability to participate in the study
18 Years
65 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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Litchfield Park, Arizona, United States
Santa Ana, California, United States
Walnut Creek, California, United States
Deerfield Beach, Florida, United States
Fort Lauderdale, Florida, United States
Fort Myers, Florida, United States
Tampa, Florida, United States
Athens, Georgia, United States
Decatur, Georgia, United States
Peoria, Illinois, United States
Evansville, Indiana, United States
Madisonville, Kentucky, United States
Columbia, Maryland, United States
Frederick, Maryland, United States
Brockton, Massachusetts, United States
Charlotte, North Carolina, United States
Winston-Salem, North Carolina, United States
Mogadore, Ohio, United States
Toledo, Ohio, United States
Goose Creek, South Carolina, United States
Memphis, Tennessee, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Richmond, Virginia, United States
Kirkland, Washington, United States
Countries
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Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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SP0887
Identifier Type: -
Identifier Source: org_study_id
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