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Tracking Information | |||||
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First Received Date † | November 9, 2006 | ||||
Last Updated Date | March 3, 2008 | ||||
Start Date † | October 2006 | ||||
Current Primary Outcome Measures † |
Average daily pain score using an 11-point Likert Scale [ Time Frame: duration of the trial ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00401830 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | A Trial to Assess Lacosamide in Subjects With Signs and Symptoms Associated With Fibromyalgia Syndrome | ||||
Official Title † | A Parallel, Randomized, Double-Blind, Placebo-Controlled, Multicenter Proof of Concept Trial to Assess the Efficacy and Safety of 400 mg/Day Lacosamide Tablets in Subjects With Signs and Symptoms Associated With Fibromyalgia Syndrome | ||||
Brief Summary | This trial will investigate the efficacy and safety of 400 mg/day of lacosamide as compared to placebo in reducing the signs and symptoms of fibromyalgia syndrome. After screening, the trial consists of 1 week Baseline Diary, 4 week Titration, 8 week double-blind Maintenance, 1 week Taper and 2 week Safety Follow-Up phases. Subjects are randomized to one of two treatment arms: lacosamide 400 mg/day or placebo during the double-blind Maintenance phase. The primary variable is the average daily pain score using an 11-point Likert scale. The secondary variables include changes in Fibromyalgia Impact Questionnaire, total myalgic score, daily interference with sleep, daily interference with general activity, Patient Global Impression of Change, and average morning/evening pain scores. Other variables include: use of rescue medication, plasma concentrations of lacosamide, assessments of adverse events (including withdrawals), changes in Hospital Anxiety Depression Scale, Fibromyalgia Symptom Checklist, laboratory parameters, vital signs, electrocardiograms (ECGs) and physical examinations. |
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Detailed Description | |||||
Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
Condition † | Fibromyalgia Syndrome | ||||
Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 416 | ||||
Completion Date | February 2008 | ||||
Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 65 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00401830 | ||||
Responsible Party | Study Director, UCB | ||||
Secondary IDs †† | |||||
Study Sponsor † | UCB | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | UCB | ||||
Verification Date | March 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |