Trial Outcomes & Findings for A Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Diabetic Neuropathy (NCT NCT00350103)

The study started to enroll patients in June 2006 and concluded in June 2007.

Participant Flow refers to the Randomized Set. The 16-week Treatment Phase consisted of 4-week Titration Phase and 12-week Maintenance Phase.

A Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Diabetic Neuropathy

An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. The value reported below is calculated as a difference between the average of the last available 28 days of maintenance for participants completing the maintenance phase (or the last 28 days prior to discontinuation for participants who discontinued in the titration or maintenance phase) and the average of the Baseline week.

Time to sustainable pain relief was defined as the time from Baseline to the first day on which there was a ≥1-point improvement over Baseline in the Likert pain score for those subjects for whom there was also ≥30% reduction in average daily pain score over the last 28 days of the Maintenance Phase as compared to Baseline.

An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening.

An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline.

An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline.

An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline.

An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline.

An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline.

An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline.

An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline. The value reported below is calculated as a difference between the average of the titration phase and the average of the Baseline Week.

An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline. The value reported below is calculated as a difference between the average of the maintenance phase and the average of the Baseline Week.

An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline. The value reported below is calculated as a difference between the average of the treatment phase and the average of the Baseline Week.

An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. A negative value indicates improvement from Baseline. The value reported below is calculated as a difference between the average of the last available 28 days of maintenance for participants completing the maintenance phase (or the last 28 days prior to discontinuation for participants who discontinued in the titration or maintenance phase) and the average of the Baseline week.

An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2.

An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2.

An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2.

An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2.

An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2.

An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2.

An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2. The value reported below is calculated as a difference between the average of the titration phase and the average of the Baseline Week.

An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2. The value reported below is calculated as a difference between the average of the maintenance phase and the average of the Baseline Week.

An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement in symptoms. A lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2. The value reported below is calculated as a difference between the average of the treatment phase and the average of the Baseline Week.

An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A lower value on the scale indicates improvement in symptoms. A negative change value indicates improvement from Baseline. Baseline Week was defined as the average of pain interference scores at the last 7 days prior to Visit 2. The value reported below is calculated as a difference between the average of the last available 28 days of maintenance for participants completing the maintenance phase (or the last 28 days prior to discontinuation for participants who discontinued in the titration or maintenance phase) and the average of the Baseline week.

An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline.

An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline.

An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline.

An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline.

An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline.

An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline.

An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline. The value reported below is calculated as a difference between the average of the titration phase and the average of the Baseline Week.

An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline. The value reported below is calculated as a difference between the average of the maintenance phase and the average of the Baseline Week.

An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline. The value reported below is calculated as a difference between the average of the treatment phase and the average of the Baseline Week.

An 11-point Likert scale was used to assess the subject's general activity. The subject rated how the pain had interfered with general activity over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement from Baseline. The value reported below is calculated as a difference between the average of the last available 28 days of maintenance for participants completing the maintenance phase (or the last 28 days prior to discontinuation for participants who discontinued in the titration or maintenance phase) and the average of the Baseline week.

Percentage of days of rescue medication use was the number of days in the visit/trial phase with rescue medication use divided by the total number of days in the visit/trial phase times 100.

Quality of life was analyzed using the Short Form-36 (SF-36) Health Survey. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 contribute to the physical component Summary (PCS) score. Items 5-8 contribute to the mental component summary (MCS) score. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive change value indicates improvement from baseline. As pre-specified in SAP, values were planned to be summarized and disclosed by placebo and LCM 400 mg/day (pooled) groups.

The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better. As pre-specified in SAP, values were planned to be summarized and disclosed by placebo and LCM 400 mg/day (pooled) reporting groups.

Categories of satisfaction are as following: very satisfied, satisfied, neither satisfied/dissatisfied, dissatisfied, very dissatisfied, not applicable, not done (no data available).

The MOS Sleep scale is used to assess the subject's quality of sleep. The scale consists of 12 individual items categorized into two sleep problems indices (SPI I/II) and 5 subscales: sleep disturbance, sleep somnolence, snoring, short of breath (SoB) or headache, sleep adequacy. Scores range from 0 to 100. Sleep adequacy scale: High values indicate a high quality of sleep. A positive change indicates improvement in quality of sleep. All other Sleep Scales: Low values indicate a high quality of sleep. A negative change indicates improvement in quality of sleep.