Status:
COMPLETED
Assessing Efficacy and Safety of Lacosamide Compared to Placebo in Reducing Signs and Symptoms of Fibromyalgia Syndrome.
Lead Sponsor:
UCB Pharma
Conditions:
Fibromyalgia Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
This was a proof-of-concept study and not powered for statistical comparisons. The trial consisted of a 4-week Titration Phase, an 8-week Maintenance Phase, a 1-week Taper Phase, and a 2-week Safety ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT00401830
Start Date
October 1 2006
End Date
February 1 2008
Last Update
July 18 2018
Active Locations (25)
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1
Litchfield Park, Arizona, United States
2
Santa Ana, California, United States, 92705
3
Walnut Creek, California, United States, 94598
4
Deerfield Beach, Florida, United States, 33064