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

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Pharma
• Treatments: Lacosamide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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