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| Sponsored by: |
UCB |
|---|---|
| Information provided by: | UCB |
| ClinicalTrials.gov Identifier: | NCT00401830 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Fibromyalgia Syndrome |
Drug: Lacosamide Other: placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Enrollment: | 416 |
| Study Start Date: | October 2006 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Placebo Comparator |
Other: placebo
placebo
|
| 2: Experimental |
Drug: Lacosamide
400mg tablet Daily
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Litchfield Park, Arizona, United States | |
| United States, California | |
| Santa Ana, California, United States, 92705 | |
| Walnut Creek, California, United States, 94598 | |
| United States, Florida | |
| Tampa, Florida, United States, 33614 | |
| Fort Myers, Florida, United States, 33916 | |
| Deerfield Beach, Florida, United States, 33064 | |
| Fort Lauderdale, Florida, United States, 33334 | |
| United States, Georgia | |
| Decatur, Georgia, United States, 30033 | |
| Athens, Georgia, United States | |
| United States, Illinois | |
| Peoria, Illinois, United States, 61614 | |
| United States, Indiana | |
| Evansville, Indiana, United States, 47714 | |
| United States, Kentucky | |
| Madisonville, Kentucky, United States, 42431 | |
| United States, Maryland | |
| Columbia, Maryland, United States, 21045 | |
| Frederick, Maryland, United States, 21702 | |
| United States, Massachusetts | |
| Brockton, Massachusetts, United States, 20301 | |
| United States, North Carolina | |
| Charlotte, North Carolina, United States, 28210 | |
| Winston Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Toledo, Ohio, United States, 43623 | |
| Mogadore, Ohio, United States, 44260 | |
| United States, South Carolina | |
| Goose Creek, South Carolina, United States, 29445 | |
| United States, Tennessee | |
| Memphis, Tennessee, United States, 30033 | |
| United States, Texas | |
| San Antonio, Texas, United States, 78213 | |
| San Antonio, Texas, United States | |
| United States, Virginia | |
| Richmond, Virginia, United States, 23294 | |
| United States, Washington | |
| Kirkland, Washington, United States, 98033 | |
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
More Information
| Responsible Party: | UCB ( Study Director ) |
| Study ID Numbers: | SP887 |
| Study First Received: | November 9, 2006 |
| Last Updated: | March 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00401830 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Signs and Symptoms Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases |
Myofascial Pain Syndromes Fibromyalgia Pain Rheumatic Diseases |
|
Signs and Symptoms Pathologic Processes Disease Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases |
Myofascial Pain Syndromes Fibromyalgia Syndrome Nervous System Diseases Rheumatic Diseases |
