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

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia Syndrome
• Intervention / Treatment: Other: Placebo; Drug: Lacosamide

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.

• Study Type: Interventional
• Enrollment (Actual): 159
• Phase: Phase 2

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Litchfield Park, Arizona, United States
  • California
    • Santa Ana, California, United States, 92705
    • Walnut Creek, California, United States, 94598
  • Florida
    • Deerfield Beach, Florida, United States, 33064
    • Fort Lauderdale, Florida, United States, 33334
    • Fort Myers, Florida, United States, 33916
    • Tampa, Florida, United States, 33614
  • Georgia
    • Athens, Georgia, United States
    • Decatur, Georgia, United States, 30033
  • Illinois
    • Peoria, Illinois, United States, 61614
  • Indiana
    • Evansville, Indiana, United States, 47714
  • Kentucky
    • Madisonville, Kentucky, United States, 42431
  • Maryland
    • Columbia, Maryland, United States, 21045
    • Frederick, Maryland, United States, 21702
  • Massachusetts
    • Brockton, Massachusetts, United States, 20301
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
    • Winston-Salem, North Carolina, United States, 27103
  • Ohio
    • Mogadore, Ohio, United States, 44260
    • Toledo, Ohio, United States, 43623
  • South Carolina
    • Goose Creek, South Carolina, United States, 29445
  • Tennessee
    • Memphis, Tennessee, United States, 30033
  • Texas
    • San Antonio, Texas, United States
    • San Antonio, Texas, United States, 78213
  • Virginia
    • Richmond, Virginia, United States, 23294
  • Washington
    • Kirkland, Washington, United States, 98033

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Other: Placebo; Matching placebo tablet administered twice daily
EXPERIMENTAL: Lacosamide; 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 and increasing to 400mg/day at weekly intervals of 100mg; Other Names: Harkoseride; Vimpat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the Last Assessment in the 12-week Treatment Phase	The Fibromyalgia Impact Questionnaire (FIQ) Total Score ranges from 0 to 100 with higher scores corresponding to a greater impact of fibromyalgia	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	Total Myalgic Score ranges from 0 to 54 with higher scores corresponding to a greater level of pain.	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	Sleep scale - the subject rated quality of sleep, from 0 (very good sleep) to 10 (very poor sleep)	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	General activity scale - the subject rated how the pain had interfered with general activity, from 0 (did not interfere) to 10 (completely interfered)	Baseline, Last 2 weeks of the 12-week Treatment Phase
Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase	The PGIC is a 7-point self-administered categorical rating scale in which the subject rated the change in pain since starting trial medication (from much worse [score of 1] to much better [score of 7]).	Baseline, Last assessment in the 12-week Treatment Phase
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the Last Assessment in the 12-week Treatment Phase	The Hospital Anxiety and Depression Scale (HADS) is a self-administered instrument for detecting anxiety and depression in medical outpatients. Scores range from 0 to 21 for each subscale with higher scores reflecting a greater level of anxiety or depression.	Baseline, Last assessment in the 12-week Treatment Phase
Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase	All scores range from 0 to 10 with higher scores corresponding to a greater level of symptom severity.	Baseline, Last assessment in the 12-week Treatment Phase
Change From Baseline in Morning Pain Score to the Last 2 Weeks of the 12-week Treatment Phase	An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).	Baseline, Last 2 weeks of the 12 week Treatment Phase
Change From Baseline in Evening Pain Score to the Last 2 Weeks of the 12-week Treatment Phase	An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).	Baseline, Last 2 weeks of the 12 week Treatment Phase
Percentage of Patients Using Rescue Medication During the 12-week Treatment Phase	Subjects recorded use of rescue medication for pain in the diary daily in the evening with a Yes/No response.	12-week Treatment Phase
Percentage of Patients Using Alcohol for Pain During the 12-week Treatment Phase	Use of alcohol to treat pain in the past 24 hours was recorded (Yes/No response).	12-week Treatment Phase
Lacosamide Plasma Concentration at the End of the Maintenance Phase/ Week 12		End of the Maintenance Phase/Week 12

Collaborators and Investigators

• Sponsor: UCB Pharma

Publications and helpful links

Helpful Links

• FDA Safety Alerts and Recalls
• Product Information

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (ACTUAL): February 1, 2008
• Study Completion (ACTUAL): February 1, 2008

Study Registration Dates

• First Submitted: November 9, 2006
• First Submitted That Met QC Criteria: November 20, 2006
• First Posted (ESTIMATE): November 22, 2006

Study Record Updates

• Last Update Posted (ACTUAL): July 18, 2018
• Last Update Submitted That Met QC Criteria: June 20, 2018
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Lacosamide; Vimpat; Fibromyalgia Syndrome; Harkoseride
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Disease; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Syndrome; Fibromyalgia; Myofascial Pain Syndromes; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lacosamide
• Other Study ID Numbers: SP0887