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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
159
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
Matching placebo tablet administered twice daily
Unnamed facility
Litchfield Park, Arizona, United States
Unnamed facility
Santa Ana, California, United States
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).
Time frame: 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).
Time frame: Baseline, Last 2 weeks of the 12-week Treatment Phase
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
Time frame: 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.
Time frame: 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)
Time frame: 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
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Unnamed facility
Walnut Creek, California, United States
Unnamed facility
Deerfield Beach, Florida, United States
Unnamed facility
Fort Lauderdale, Florida, United States
Unnamed facility
Fort Myers, Florida, United States
Unnamed facility
Tampa, Florida, United States
Unnamed facility
Athens, Georgia, United States
Unnamed facility
Decatur, Georgia, United States
Unnamed facility
Peoria, Illinois, United States
...and 15 more locations
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
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).
Time frame: 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).
Time frame: 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 \[score of 7\]).
Time frame: 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.
Time frame: Baseline, Last assessment in 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.
Time frame: 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).
Time frame: 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.
Time frame: Baseline, Last assessment in the 12-week Treatment Phase
Lacosamide Plasma Concentration at the End of the Maintenance Phase/ Week 12
Time frame: End of the Maintenance Phase/Week 12