Assessing Efficacy and Safety of Lacosamide Compared to Placebo in Reducing Signs and Symptoms of 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 400mg/day of lacosamide as compared to placebo in reducing the signs and symptoms of fibromyalgia syndrome.

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

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia

U.S. FDA Resources

Further study details as provided by UCB:

Primary Outcome Measures:

Change from Baseline in average daily pain score to the last 2 weeks of the 12-week Treatment Phase (based on the Full Analysis Set) [ Time Frame: Baseline, Last 2 weeks of the 12 week Treatment Phase ] [ Designated as safety issue: No ]
Change from Baseline in average daily pain score to the last 2 weeks of the 12-week Treatment Phase (based on the Per Protocol Set) [ Time Frame: Baseline, Last 2 weeks of the 12 week Treatment Phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the last assessment in the 12-week Treatment Phase [ Time Frame: Baseline, Last assessment in the 12-week Treatment Phase ] [ Designated as safety issue: No ]
Change from Baseline in Total Myalgic Score to the last assessment in the 12-week Treatment Phase [ Time Frame: Baseline, Last assessment in the 12-week Treatment Phase ] [ Designated as safety issue: No ]
Change from Baseline in average daily interference with sleep to the last 2 weeks of the 12-week Treatment Phase [ Time Frame: Baseline, Last 2 weeks of the 12 week Treatment Phase ] [ Designated as safety issue: No ]
Change from Baseline in daily interference with general activity to the last 2 weeks of the 12-week Treatment Phase [ Time Frame: Baseline, Last 2 weeks of the 12 week Treatment Phase ] [ Designated as safety issue: No ]
Change from Baseline in morning pain score to the last 2 weeks of the 12-week Treatment Phase [ Time Frame: Baseline, Last 2 weeks of the 12 week Treatment Phase ] [ Designated as safety issue: No ]
Change from Baseline in evening pain score to the last 2 weeks of the 12-week Treatment Phase [ Time Frame: Baseline, Last 2 weeks of the 12 week Treatment Phase ] [ Designated as safety issue: No ]
Patient Global Impression of Change (PGIC) Assessment from Baseline to the last assessment in the 12-week Treatment Phase) [ Time Frame: Baseline, Last assessment in the 12-week Treatment Phase ] [ Designated as safety issue: No ]
Change from Baseline in Hospital Anxiety Depression Scale (HADS) scores to the last assessment in the 12-week Treatment Phase [ Time Frame: Baseline, Last assessment in the 12-week Treatment Phase ] [ Designated as safety issue: No ]
Percentage of patients using rescue medication during the 12-week Treatment Phase [ Time Frame: 12-week Treatment Phase ] [ Designated as safety issue: No ]
Percentage of patients using alcohol for pain during the 12-week Treatment Phase [ Time Frame: 12-week Treatment Phase ] [ Designated as safety issue: No ]
Change from Baseline in Fibromyalgia Symptom Scores to the last assessment in the 12-week Treatment Phase [ Time Frame: Baseline, Last assessment in the 12-week Treatment Phase ] [ Designated as safety issue: No ]
Lacosamide Plasma Concentration at the End of the Maintenance Phase/ Week 12 [ Time Frame: End of the Maintenance Phase/Week 12 ] [ Designated as safety issue: No ]

Enrollment:	159
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
Placebo: Placebo Comparator	Other: placebo Matching placebo tablet administered twice daily
Lacosamide: Experimental Lacosamide Tablet 400mg daily	Drug: Lacosamide Tablet 400mg daily (200mg twice daily) during 8-week maintenance phase following 4-week titration phase starting at 100mg/day to 400mg/day at weekly intervals of 100mg

Detailed Description:

This was a proof-of-concept study and not powered for statistical comparisons.

The trial consisted of a 4-week Titration Phase, an 8-week Maintenance Phase, a 1-week Taper Phase, and a 2-week Safety Follow-Up Phase. If subjects met the eligibility criteria, they were randomized to receive either lacosamide 400mg/day or placebo during the Maintenance Phase. Subjects assigned to lacosamide were titrated from 100mg/day to 400mg/day at weekly intervals of 100mg. All subjects who completed the 4-week Titration Phase entered an 8-week Maintenance Phase. No dose adjustment was allowed during the Maintenance Phase. The Treatment Phase was defined as the combined Titration and Maintenance Phases.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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:	July 8, 2009
ClinicalTrials.gov Identifier:	NCT00401830 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by UCB:

Fibromyagia Syndrome
Lacosamide
Vimpat
Harkoseride

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 September 03, 2009