Assessing Efficacy and Safety of Lacosamide Compared to Placebo in Reducing Signs and Symptoms of Fibromyalgia Syndrome.
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
1 other identifier
interventional
159
1 country
25
Brief Summary
This trial investigated the efficacy and safety of 400mg/day of lacosamide as compared to placebo in reducing the signs and symptoms of fibromyalgia syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2006
Shorter than P25 for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 9, 2006
CompletedFirst Posted
Study publicly available on registry
November 22, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedResults Posted
Study results publicly available
October 22, 2009
CompletedJuly 18, 2018
July 1, 2017
1.3 years
November 9, 2006
September 22, 2009
June 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).
Baseline, Last 2 weeks of the 12-week Treatment Phase
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)
The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).
Baseline, Last 2 weeks of the 12-week Treatment Phase
Secondary Outcomes (12)
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the Last Assessment in the 12-week Treatment Phase
Baseline, Last assessment in the 12-week Treatment Phase
Change From Baseline in Total Myalgic Score to the Last Assessment in the 12-week Treatment Phase
Baseline, Last assessment in the 12-week Treatment Phase
Change From Baseline in Average Daily Interference With Sleep to the Last 2 Weeks of the 12-week Treatment Phase
Baseline, Last 2 weeks of the 12-week Treatment Phase
Change From Baseline in Daily Interference With General Activity to the Last 2 Weeks of the 12-week Treatment Phase
Baseline, Last 2 weeks of the 12-week Treatment Phase
Change From Baseline in Morning Pain Score to the Last 2 Weeks of the 12-week Treatment Phase
Baseline, Last 2 weeks of the 12 week Treatment Phase
- +7 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORLacosamide
EXPERIMENTALLacosamide Tablet 400mg daily
Interventions
Tablet 400mg daily (200mg twice daily) during 8-week maintenance phase following 4-week titration phase starting at 100mg/day and increasing to 400mg/day at weekly intervals of 100mg
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (25)
Unknown Facility
Litchfield Park, Arizona, United States
Unknown Facility
Santa Ana, California, 92705, United States
Unknown Facility
Walnut Creek, California, 94598, United States
Unknown Facility
Deerfield Beach, Florida, 33064, United States
Unknown Facility
Fort Lauderdale, Florida, 33334, United States
Unknown Facility
Fort Myers, Florida, 33916, United States
Unknown Facility
Tampa, Florida, 33614, United States
Unknown Facility
Athens, Georgia, United States
Unknown Facility
Decatur, Georgia, 30033, United States
Unknown Facility
Peoria, Illinois, 61614, United States
Unknown Facility
Evansville, Indiana, 47714, United States
Unknown Facility
Madisonville, Kentucky, 42431, United States
Unknown Facility
Columbia, Maryland, 21045, United States
Unknown Facility
Frederick, Maryland, 21702, United States
Unknown Facility
Brockton, Massachusetts, 20301, United States
Unknown Facility
Charlotte, North Carolina, 28210, United States
Unknown Facility
Winston-Salem, North Carolina, 27103, United States
Unknown Facility
Mogadore, Ohio, 44260, United States
Unknown Facility
Toledo, Ohio, 43623, United States
Unknown Facility
Goose Creek, South Carolina, 29445, United States
Unknown Facility
Memphis, Tennessee, 30033, United States
Unknown Facility
San Antonio, Texas, 78213, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Richmond, Virginia, 23294, United States
Unknown Facility
Kirkland, Washington, 98033, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- UCB Clinical Trial Call Center
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
November 9, 2006
First Posted
November 22, 2006
Study Start
October 1, 2006
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
July 18, 2018
Results First Posted
October 22, 2009
Record last verified: 2017-07