| 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). | 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. | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline, Last 2 weeks of the 12-week Treatment Phase | | | | ID | Title | Description |
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| OG000 | Placebo | Matching placebo tablet (administered twice daily) | | OG001 | Lacosamide | Lacosamide Tablet 400mg daily (administered twice daily) |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-1.30± 1.92
- OG001-1.80± 2.13
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| 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). | 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. | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline, Last 2 weeks of the 12-week Treatment Phase | | | | ID | Title | Description |
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| OG000 | Placebo | Matching placebo tablet (administered twice daily) | | OG001 | Lacosamide | Lacosamide Tablet 400mg daily (administered twice daily) |
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| 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 | 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. | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline, Last assessment in the 12-week Treatment Phase | | | | ID | Title | Description |
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| OG000 | Placebo | Matching placebo tablet (administered twice daily) | | OG001 | Lacosamide | Lacosamide Tablet 400mg daily (administered twice daily) |
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| 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. | 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. | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline, Last assessment in the 12-week Treatment Phase | | | | ID | Title | Description |
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| OG000 | Placebo | Matching placebo tablet (administered twice daily) | | OG001 | Lacosamide | Lacosamide Tablet 400mg daily (administered twice daily) |
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| 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) | 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. | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline, Last 2 weeks of the 12-week Treatment Phase | | | | ID | Title | Description |
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| OG000 | Placebo | Matching placebo tablet (administered twice daily) | | OG001 | Lacosamide | Lacosamide Tablet 400mg daily (administered twice daily) |
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| 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) | 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. | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline, Last 2 weeks of the 12-week Treatment Phase | | | | ID | Title | Description |
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| OG000 | Placebo | Matching placebo tablet (administered twice daily) | | OG001 | Lacosamide | Lacosamide Tablet 400mg daily (administered twice daily) |
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| 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). | 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. | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline, Last 2 weeks of the 12 week Treatment Phase | | | | ID | Title | Description |
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| OG000 | Placebo | Matching placebo tablet (administered twice daily) | | OG001 | Lacosamide | Lacosamide Tablet 400mg daily (administered twice daily) |
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| 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). | 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. | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline, Last 2 weeks of the 12 week Treatment Phase | | | | ID | Title | Description |
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| OG000 | Placebo | Matching placebo tablet (administered twice daily) | | OG001 | Lacosamide | Lacosamide Tablet 400mg daily (administered twice daily) |
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| 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]). | 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. | Posted | | Number | | Patients | | Baseline, Last assessment in the 12-week Treatment Phase | | | | ID | Title | Description |
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| OG000 | Placebo | Matching placebo tablet (administered twice daily) | | OG001 | Lacosamide | Lacosamide Tablet 400mg daily (administered twice daily) |
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| 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. | 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. | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline, Last assessment in the 12-week Treatment Phase | | | | ID | Title | Description |
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| OG000 | Placebo | Matching placebo tablet (administered twice daily) | | OG001 | Lacosamide | Lacosamide Tablet 400mg daily (administered twice daily) |
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| 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. | 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. | Posted | | Number | | Percentage of patients | | 12-week Treatment Phase | | | | ID | Title | Description |
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| OG000 | Placebo | Matching placebo tablet (administered twice daily) | | OG001 | Lacosamide | Lacosamide Tablet 400mg daily (administered twice daily) |
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| 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). | 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. | Posted | | Number | | Percentage of patients | | 12-week Treatment Phase | | | | ID | Title | Description |
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| OG000 | Placebo | Matching placebo tablet (administered twice daily) | | OG001 | Lacosamide | Lacosamide Tablet 400mg daily (administered twice daily) |
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| 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. | 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. | Posted | | Mean | Standard Deviation | Score on a scale | | Baseline, Last assessment in the 12-week Treatment Phase | | | | ID | Title | Description |
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| OG000 | Placebo | Matching placebo tablet (administered twice daily) | | OG001 | Lacosamide | Lacosamide Tablet 400mg daily (administered twice daily) |
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| Secondary | Lacosamide Plasma Concentration at the End of the Maintenance Phase/ Week 12 | | 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. | Posted | | Mean | Standard Deviation | ug/ML | | End of the Maintenance Phase/Week 12 | | | | ID | Title | Description |
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| OG000 | Placebo | Matching placebo tablet (administered twice daily) | | OG001 | Lacosamide | Lacosamide Tablet 400mg daily (administered twice daily) |
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