Back to resultsAssessing Efficacy and Safety of Lacosamide Compared to Placebo in Reducing Signs and Symptoms of Fibromyalgia Syndrome.
Primary Purpose
Fibromyalgia Syndrome
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lacosamide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia Syndrome focused on measuring Fibromyalgia Syndrome, Lacosamide, Vimpat, Harkoseride
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Lacosamide
Arm Description
Lacosamide Tablet 400mg daily
Outcomes
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)
The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).
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).
Secondary Outcome Measures
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
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.
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)
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)
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).
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).
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]).
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.
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.
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).
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.
Lacosamide Plasma Concentration at the End of the Maintenance Phase/ Week 12
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00401830
Brief Title
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
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia Syndrome
Keywords
Fibromyalgia Syndrome, Lacosamide, Vimpat, Harkoseride
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
159 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Lacosamide
Arm Type
Experimental
Arm Description
Lacosamide Tablet 400mg daily
Intervention Type
Drug
Intervention Name(s)
Lacosamide
Other Intervention Name(s)
Vimpat, Harkoseride
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Matching placebo tablet administered twice daily
Primary Outcome Measure Information:
Title
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)
Description
The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).
Time Frame
Baseline, Last 2 weeks of the 12-week Treatment Phase
Title
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)
Description
The average daily pain score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).
Time Frame
Baseline, Last 2 weeks of the 12-week Treatment Phase
Secondary Outcome Measure Information:
Title
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the Last Assessment in the 12-week Treatment Phase
Description
The Fibromyalgia Impact Questionnaire (FIQ) Total Score ranges from 0 to 100 with higher scores corresponding to a greater impact of fibromyalgia
Time Frame
Baseline, Last assessment in the 12-week Treatment Phase
Title
Change From Baseline in Total Myalgic Score to the Last Assessment in the 12-week Treatment Phase
Description
Total Myalgic Score ranges from 0 to 54 with higher scores corresponding to a greater level of pain.
Time Frame
Baseline, Last assessment in the 12-week Treatment Phase
Title
Change From Baseline in Average Daily Interference With Sleep to the Last 2 Weeks of the 12-week Treatment Phase
Description
Sleep scale - the subject rated quality of sleep, from 0 (very good sleep) to 10 (very poor sleep)
Time Frame
Baseline, Last 2 weeks of the 12-week Treatment Phase
Title
Change From Baseline in Daily Interference With General Activity to the Last 2 Weeks of the 12-week Treatment Phase
Description
General activity scale - the subject rated how the pain had interfered with general activity, from 0 (did not interfere) to 10 (completely interfered)
Time Frame
Baseline, Last 2 weeks of the 12-week Treatment Phase
Title
Change From Baseline in Morning Pain Score to the Last 2 Weeks of the 12-week Treatment Phase
Description
An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).
Time Frame
Baseline, Last 2 weeks of the 12 week Treatment Phase
Title
Change From Baseline in Evening Pain Score to the Last 2 Weeks of the 12-week Treatment Phase
Description
An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced).
Time Frame
Baseline, Last 2 weeks of the 12 week Treatment Phase
Title
Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase
Description
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]).
Time Frame
Baseline, Last assessment in the 12-week Treatment Phase
Title
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the Last Assessment in the 12-week Treatment Phase
Description
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.
Time Frame
Baseline, Last assessment in the 12-week Treatment Phase
Title
Percentage of Patients Using Rescue Medication During the 12-week Treatment Phase
Description
Subjects recorded use of rescue medication for pain in the diary daily in the evening with a Yes/No response.
Time Frame
12-week Treatment Phase
Title
Percentage of Patients Using Alcohol for Pain During the 12-week Treatment Phase
Description
Use of alcohol to treat pain in the past 24 hours was recorded (Yes/No response).
Time Frame
12-week Treatment Phase
Title
Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase
Description
All scores range from 0 to 10 with higher scores corresponding to a greater level of symptom severity.
Time Frame
Baseline, Last assessment in the 12-week Treatment Phase
Title
Lacosamide Plasma Concentration at the End of the Maintenance Phase/ Week 12
Time Frame
End of the Maintenance Phase/Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
City
Litchfield Park
State/Province
Arizona
Country
United States
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
City
Athens
State/Province
Georgia
Country
United States
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
20301
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Mogadore
State/Province
Ohio
ZIP/Postal Code
44260
Country
United States
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
City
Goose Creek
State/Province
South Carolina
ZIP/Postal Code
29445
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
30033
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98033
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
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Assessing Efficacy and Safety of Lacosamide Compared to Placebo in Reducing Signs and Symptoms of Fibromyalgia Syndrome.
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