Assessing Efficacy and Safety of Lacosamide Compared to Placebo in Reducing Signs and Symptoms of Fibromyalgia Syndrome.

Completed · Phase 2 · Has a placebo group

Conditions studied: Fibromyalgia Syndrome

In brief

This trial investigated the efficacy and safety of 400mg/day of lacosamide as compared to placebo in reducing the signs and symptoms of fibromyalgia syndrome.

Key facts

Study ID

NCT00401830

Run by

UCB Pharma

People needed

159

Starts

2006-10-01

Expected to finish

2008-02-01

Last updated by the study team

2018-07-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females, 18 to 65 years old
• 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

You may not qualify if…

• Symptomatic regional or structural rheumatic disease
• 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

Where it is running

• Study site — Litchfield Park, Arizona, United States
• Study site — Santa Ana, California, United States
• Study site — Walnut Creek, California, United States
• Study site — Deerfield Beach, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Fort Myers, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Athens, Georgia, United States
• Study site — Decatur, Georgia, United States
• Study site — Peoria, Illinois, United States
• Study site — Evansville, Indiana, United States
• Study site — Madisonville, Kentucky, United States
• Study site — Columbia, Maryland, United States
• Study site — Frederick, Maryland, United States
• Study site — Brockton, Massachusetts, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Mogadore, Ohio, United States
• Study site — Toledo, Ohio, United States
• Study site — Goose Creek, South Carolina, United States
• Study site — Memphis, Tennessee, United States
• Study site — San Antonio, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Richmond, Virginia, United States
• Study site — Kirkland, Washington, United States

Full record on ClinicalTrials.gov

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