Fibromyalgia Syndrome
Conditions
Keywords
Fibromyalgia Syndrome, Lacosamide, Vimpat, Harkoseride
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.
Interventions
DRUGLacosamide
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
OTHERPlacebo
Matching placebo tablet administered twice daily
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Baseline, Last 2 weeks of the 12-week Treatment Phase | 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) | Baseline, Last 2 weeks of the 12-week Treatment Phase | 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Evening Pain Score to the Last 2 Weeks of the 12-week Treatment Phase | Baseline, 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 | Baseline, 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 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 | 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 | Baseline, 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 | Baseline, 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 | Baseline, 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) |
| Percentage of Patients Using Rescue Medication During the 12-week Treatment Phase | 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 | 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 | Baseline, 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 | End of the Maintenance Phase/Week 12 | — |
| Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the Last Assessment in the 12-week Treatment Phase | Baseline, 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. |
| 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 | An 11-point Likert scale was used for subjects to assess pain, from 0 (no pain) to 10 (worst pain ever experienced). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Matching placebo tablet (administered twice daily) | 81 |
| Lacosamide Lacosamide Tablet 400mg daily (administered twice daily) | 78 |
| Total | 159 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 10 | 18 |
| Overall Study | Lack of Efficacy | 11 | 5 |
| Overall Study | Lost to Follow-up | 1 | 3 |
| Overall Study | Non-compliance with drug study | 1 | 0 |
| Overall Study | Other: Personal / Family problems | 1 | 0 |
| Overall Study | Protocol Violation | 3 | 3 |
| Overall Study | Withdrawal by Subject | 4 | 3 |
Baseline characteristics
| Characteristic | Lacosamide | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 76 Participants | 79 Participants | 155 Participants |
| Age, Continuous | 48.9 years STANDARD_DEVIATION 11.1 | 50.4 years STANDARD_DEVIATION 10.5 | 49.7 years STANDARD_DEVIATION 10.8 |
| Region of Enrollment United States | 78 participants | 81 participants | 159 participants |
| Sex: Female, Male Female | 71 Participants | 77 Participants | 148 Participants |
| Sex: Female, Male Male | 7 Participants | 4 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 37 / 81 | 53 / 78 |
| serious Total, serious adverse events | 3 / 81 | 0 / 78 |
Outcome results
Primary
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
Population: Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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) | -1.30 Score on a scale | Standard Deviation 1.92 |
| Lacosamide | 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) | -1.80 Score on a scale | Standard Deviation 2.13 |
Primary
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
Population: Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 36 and 41 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Per Protocol Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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) | -2.11 Score on a scale | Standard Deviation 1.98 |
| Lacosamide | 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) | -2.40 Score on a scale | Standard Deviation 2.08 |
Secondary
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
Population: Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Average Daily Interference With Sleep to the Last 2 Weeks of the 12-week Treatment Phase | -1.24 Score on a scale | Standard Deviation 1.94 |
| Lacosamide | Change From Baseline in Average Daily Interference With Sleep to the Last 2 Weeks of the 12-week Treatment Phase | -1.64 Score on a scale | Standard Deviation 2.16 |
Secondary
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)
Time frame: Baseline, Last 2 weeks of the 12-week Treatment Phase
Population: Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Daily Interference With General Activity to the Last 2 Weeks of the 12-week Treatment Phase | -1.27 Score on a scale | Standard Deviation 1.93 |
| Lacosamide | Change From Baseline in Daily Interference With General Activity to the Last 2 Weeks of the 12-week Treatment Phase | -1.44 Score on a scale | Standard Deviation 2.3 |
Secondary
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
Population: Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Evening Pain Score to the Last 2 Weeks of the 12-week Treatment Phase | -1.32 Score on a scale | Standard Deviation 1.94 |
| Lacosamide | Change From Baseline in Evening Pain Score to the Last 2 Weeks of the 12-week Treatment Phase | -1.84 Score on a scale | Standard Deviation 2.15 |
Secondary
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
Population: Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 79 and 78 patients respectively are included in this summary based on the Full Analysis Set and have the Last Assessment in the 12-week Treatment Phase.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the Last Assessment in the 12-week Treatment Phase | -14.7 Score on a scale | Standard Deviation 16.9 |
| Lacosamide | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score to the Last Assessment in the 12-week Treatment Phase | -17.5 Score on a scale | Standard Deviation 19.3 |
Secondary
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
Population: Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 61 and 60 patients respectively are included in this summary based on the Full Analysis Set and have the Last Assessment in the 12-week Treatment Phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase | Joint pains | -1.9 Score on a scale | Standard Deviation 2.8 |
| Placebo | Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase | Paresthesias | -1.6 Score on a scale | Standard Deviation 2.6 |
| Placebo | Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase | Insomnia | -1.9 Score on a scale | Standard Deviation 2.7 |
| Placebo | Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase | Impaired memory | -1.3 Score on a scale | Standard Deviation 2.7 |
| Placebo | Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase | Headaches | -0.7 Score on a scale | Standard Deviation 3.2 |
| Placebo | Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase | Leg cramps | -1.5 Score on a scale | Standard Deviation 2.8 |
| Placebo | Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase | Fatigue | -1.7 Score on a scale | Standard Deviation 2.4 |
| Placebo | Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase | Impaired concentration | -1.2 Score on a scale | Standard Deviation 3.1 |
| Placebo | Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase | Restless legs | -1.5 Score on a scale | Standard Deviation 2.9 |
| Placebo | Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase | Abdominal pain, alternating diarrhea/constipation | -1.7 Score on a scale | Standard Deviation 3.4 |
| Placebo | Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase | Muscular Pain | -1.9 Score on a scale | Standard Deviation 2.4 |
| Lacosamide | Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase | Abdominal pain, alternating diarrhea/constipation | -1.2 Score on a scale | Standard Deviation 3.5 |
| Lacosamide | Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase | Muscular Pain | -2.4 Score on a scale | Standard Deviation 2.9 |
| Lacosamide | Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase | Fatigue | -1.9 Score on a scale | Standard Deviation 2.9 |
| Lacosamide | Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase | Insomnia | -2.4 Score on a scale | Standard Deviation 3.2 |
| Lacosamide | Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase | Joint pains | -1.9 Score on a scale | Standard Deviation 3.3 |
| Lacosamide | Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase | Headaches | -1.2 Score on a scale | Standard Deviation 3.5 |
| Lacosamide | Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase | Restless legs | -1.2 Score on a scale | Standard Deviation 3.3 |
| Lacosamide | Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase | Paresthesias | -1.3 Score on a scale | Standard Deviation 3.1 |
| Lacosamide | Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase | Impaired memory | 0.0 Score on a scale | Standard Deviation 3.1 |
| Lacosamide | Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase | Leg cramps | -1.4 Score on a scale | Standard Deviation 2.8 |
| Lacosamide | Change From Baseline in Fibromyalgia Symptom Scores to the Last Assessment in the 12-week Treatment Phase | Impaired concentration | -0.5 Score on a scale | Standard Deviation 3.1 |
Secondary
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
Population: Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the Full Analysis Set (FAS). A total of 67 subjects in each treatment group in the FAS have change from Baseline data for depression. One subject in the Lacosamide group had a missing anxiety score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the Last Assessment in the 12-week Treatment Phase | Depression score (Placebo n=67, Lacosamide n=67) | -1.1 Score on a scale | Standard Deviation 2.8 |
| Placebo | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the Last Assessment in the 12-week Treatment Phase | Anxiety Score (Placebo n=67, Lacosamide n=66) | -1.2 Score on a scale | Standard Deviation 3.2 |
| Lacosamide | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the Last Assessment in the 12-week Treatment Phase | Depression score (Placebo n=67, Lacosamide n=67) | -0.8 Score on a scale | Standard Deviation 2.8 |
| Lacosamide | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores to the Last Assessment in the 12-week Treatment Phase | Anxiety Score (Placebo n=67, Lacosamide n=66) | -1.2 Score on a scale | Standard Deviation 3.2 |
Secondary
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
Population: Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the summary of the last 2 weeks of the 12-week Treatment Phase, based on the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Morning Pain Score to the Last 2 Weeks of the 12-week Treatment Phase | -1.29 Score on a scale | Standard Deviation 1.97 |
| Lacosamide | Change From Baseline in Morning Pain Score to the Last 2 Weeks of the 12-week Treatment Phase | -1.77 Score on a scale | Standard Deviation 2.18 |
Secondary
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
Population: Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 79 and 78 patients respectively are included in this summary based on the Full Analysis Set and have the Last Assessment in the 12-week Treatment Phase.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Total Myalgic Score to the Last Assessment in the 12-week Treatment Phase | -6.7 Score on a scale | Standard Deviation 13.6 |
| Lacosamide | Change From Baseline in Total Myalgic Score to the Last Assessment in the 12-week Treatment Phase | -9.7 Score on a scale | Standard Deviation 13 |
Secondary
Lacosamide Plasma Concentration at the End of the Maintenance Phase/ Week 12
Time frame: End of the Maintenance Phase/Week 12
Population: The number of patients in the Placebo treatment group has been presented as 0 as this outcome measure is not applicable for this treatment group. Of the 78 patients in the Lacosamide treatment group (Safety Set) data were available at the end of Maintenance Phase/Week 12 for the 45 patients remaining in the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lacosamide | Lacosamide Plasma Concentration at the End of the Maintenance Phase/ Week 12 | 9.44 ug/ML | Standard Deviation 5.24 |
Secondary
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
Population: Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in the Full Analysis Set (FAS). A total of 67 subjects in each treatment group in the FAS have this assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | Mildly better | 18 Patients |
| Placebo | Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | Mildly worse | 5 Patients |
| Placebo | Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | Moderately better | 14 Patients |
| Placebo | Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | Moderately worse | 2 Patients |
| Placebo | Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | No change | 17 Patients |
| Placebo | Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | Much worse | 3 Patients |
| Placebo | Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | Much better | 8 Patients |
| Lacosamide | Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | Much worse | 3 Patients |
| Lacosamide | Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | Much better | 17 Patients |
| Lacosamide | Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | Moderately better | 12 Patients |
| Lacosamide | Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | Mildly better | 13 Patients |
| Lacosamide | Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | No change | 13 Patients |
| Lacosamide | Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | Mildly worse | 3 Patients |
| Lacosamide | Patient Global Impression of Change (PGIC) Assessment From Baseline to the Last Assessment in the 12-week Treatment Phase | Moderately worse | 6 Patients |
Secondary
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
Population: Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in this summary based on the Full Analysis Set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Patients Using Alcohol for Pain During the 12-week Treatment Phase | 17.5 Percentage of patients |
| Lacosamide | Percentage of Patients Using Alcohol for Pain During the 12-week Treatment Phase | 15.4 Percentage of patients |
Secondary
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
Population: Of the 81 (Placebo) and 78 (Lacosamide) patients randomized, 80 and 78 patients respectively are included in this summary based on the Full Analysis Set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Patients Using Rescue Medication During the 12-week Treatment Phase | 83.8 Percentage of patients |
| Lacosamide | Percentage of Patients Using Rescue Medication During the 12-week Treatment Phase | 83.3 Percentage of patients |