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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

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 ^†

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 ]

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.

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 ^†

Drug: Lacosamide
Other: placebo

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.

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:

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

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 ^†

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

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.