Clinical trial NCT00401830: Assessing Efficacy and Safety of Lacosamide Compared to Placebo in Reducing Signs and Symptoms of 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fibromyalgia Syndrome
Keywords: Fibromyalgia Syndrome
Lacosamide
Vimpat
Harkoseride
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2006-11-22
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: 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)
timeFrame: Baseline, Last 2 weeks of the 12-week Treatment Phase
measure: 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)
timeFrame: Baseline, Last 2 weeks of the 12-week Treatment Phase
Secondary outcomes:
measure: Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the Last Assessment in the 12-week Treatment Phase
timeFrame: Baseline, Last assessment in the 12-week Treatment Phase
measure: Change From Baseline in Total Myalgic Score to the Last Assessment in the 12-week Treatment Phase
timeFrame: Baseline, Last assessment in the 12-week Treatment Phase
measure: Change From Baseline in Average Daily Interference With Sleep to the Last 2 Weeks of the 12-week Treatment Phase
timeFrame: Baseline, Last 2 weeks of the 12-week Treatment Phase
measure: Change From Baseline in Daily Interference With General Activity to the Last 2 Weeks of the 12-week Treatment Phase
timeFrame: Baseline, Last 2 weeks of the 12-week Treatment Phase
measure: Change From Baseline in Morning Pain Score to the Last 2 Weeks of the 12-week Treatment Phase
timeFrame: Baseline, Last 2 weeks of the 12 week Treatment Phase
measure: Change From Baseline in Evening Pain Score to the Last 2 Weeks of the 12-week Treatment Phase
timeFrame: Baseline, Last 2 weeks of the 12 week Treatment Phase
measure: Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase
timeFrame: Baseline, Last assessment in the 12-week Treatment Phase
measure: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the Last Assessment in the 12-week Treatment Phase
timeFrame: Baseline, Last assessment in the 12-week Treatment Phase
measure: Percentage of Patients Using Rescue Medication During the 12-week Treatment Phase
timeFrame: 12-week Treatment Phase
measure: Percentage of Patients Using Alcohol for Pain During the 12-week Treatment Phase
timeFrame: 12-week Treatment Phase
measure: Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase
timeFrame: Baseline, Last assessment in the 12-week Treatment Phase
measure: Lacosamide Plasma Concentration at the End of the Maintenance Phase/ Week 12
timeFrame: End of the Maintenance Phase/Week 12
Other outcomes:
Locations:
city: Litchfield Park
country: United States
state: Arizona
city: Santa Ana
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: Deerfield Beach
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Athens
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Peoria
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Madisonville
country: United States
state: Kentucky
city: Columbia
country: United States
state: Maryland
city: Frederick
country: United States
state: Maryland
city: Brockton
country: United States
state: Massachusetts
city: Charlotte
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Mogadore
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Goose Creek
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Kirkland
country: United States
state: Washington
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: