A Trial to Assess Lacosamide in Subjects With Signs and Symptoms Associated With Fibromyalgia Syndrome - Full Text View

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

MedlinePlus related topics: Anxiety Depression Fibromyalgia

U.S. FDA Resources

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

Further study details as provided by UCB:

Primary Outcome Measures:

Average daily pain score using an 11-point Likert Scale [ Time Frame: duration of the trial ]

Secondary Outcome Measures:

Fibromyalgia Impact Questionnaire [ Time Frame: duration of the trial ]
Daily interference with sleep [ Time Frame: duration of the trial ]
Daily interference with general activity [ Time Frame: duration of the trial ]
Total myalgic score [ Time Frame: duration of the trial ]
Patient Global Impression of Change [ Time Frame: duration of the trial ]
Average morning/evening pain scores [ Time Frame: duration of the trial ]
Use of rescue medication [ Time Frame: duration of the trial ]
Plasma concentrations of lacosamide [ Time Frame: duration of the trial ]
Assessments of adverse events (including withdrawals) [ Time Frame: duration of the trial ]
Changes in Hospital Anxiety Depression Scale [ Time Frame: duration of the trial ]
Fibromyalgia symptom checklist [ Time Frame: duration of the trial ]
Laboratory parameters [ Time Frame: duration of the trial ]
Vital signs [ Time Frame: duration of the trial ]
ECGs [ Time Frame: duration of the trial ]
Physical examinations [ Time Frame: duration of the trial ]

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

Criteria

Inclusion Criteria:

Subject must have signs and symptoms of idiopathic/primary fibromyalgia that is documented as lasting > 3 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401830

Show 25 Study Locations

Sponsors and Collaborators

UCB

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

No publications provided

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

Study placed in the following topic categories:

Signs and Symptoms
Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases

Myofascial Pain Syndromes
Fibromyalgia
Pain
Rheumatic Diseases

Additional relevant MeSH terms:

Signs and Symptoms
Pathologic Processes
Disease
Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases

Myofascial Pain Syndromes
Fibromyalgia
Syndrome
Nervous System Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 06, 2009