Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period |
Percentage change from baseline=[(12 week treatment observation period seizure frequency rate minus 8 week baseline period seizure frequency rate)/ 8 week baseline period seizure frequency rate] x 100. Seizure frequencies per 28-day period: = (total # of partial seizures in period x 28 / (total # of days in period). |
8 week baseline period & 12 week treatment observation period |
|
Secondary |
Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the Whole 21 Week Open-label Treatment Period. |
Percentage change from baseline = ((21 weeks-8 weeks)/8 weeks)*100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency. |
8 week baseline period and 21 week treatment period |
|
Secondary |
Percentage Change in Partial Seizure Frequency (All Partial Seizure Types) Between the 8 Week Baseline Period and 4 Week Intervals During the 21 Week Open-label Treatment Period. |
Percentage change from baseline = [(4 week seizure frequency minus 8 week baseline) / (8 week baseline seizure frequency)] x 100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency. |
8 week baseline period and 21 week treatment period |
|
Secondary |
Number of Subjects Seizure-free |
Count of subjects seizure free during the period. |
last 4 weeks & whole 12 week treatment observation period |
|
Secondary |
Reduction in Partial Seizure Frequency Between Baseline and the Final 4 Weeks of the Observation Period. |
Number of subjects with at least a 50% or 75% reduction in partial seizure frequency between baseline and treatment period. |
8 week baseline observation period & last 4 weeks of observation period |
|
Secondary |
Subjects Achieving Seizure Freedom During Observation Period |
Number of subjects achieving seizure freedom (no seizures) during last 4 weeks or duration of 12 week observation period. |
Day 147 from the first dose of study drug |
|
Secondary |
Change in Partial Seizure Frequency (All Partial Seizure Types) Between Baseline and the 12 Week Observation Period Categorized by Baseline Seizure Frequency |
Percentage change from baseline = ((12 weeks - 8 weeks)/8 weeks)*100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency. |
8 week baseline observation period & 12 week treatment observation period |
|
Secondary |
Impression of Change in Overall Status Using the Patient Global Impression of Change (PGIC) |
The PGIC is a patient-rated instrument that measures change in patient's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). |
End of 21-week treatment |
|
Secondary |
Subjects With Categorical Impression of Change in Overall Status Using the Clinical Global Impression of Change (CGIC) |
The CGIC is a clinician's judgment of the overall change in the patient's condition over a defined period on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). |
End of 21-week treatment |
|
Secondary |
Changes From Baseline in Medical Outcomes Study (MOS) Sleep Scale Scores |
Subjects recall sleep related activities over the previous 4 weeks. Low scores reflect greater impairment (except sleep adequacy, optimal sleep, &quantity). Range = 0 - 100 for Sleep Disturbance, Snoring, Awaken Short of Breath, Sleep Adequacy, Somnolence, & Sleep Problems Index. Quantity of Sleep Range = 0 - 24. Optimal Sleep Range 0 - 1. |
Baseline, end of 21-week treatment |
|
Secondary |
Change From Baseline in Hospital Anxiety and Depression Scale(HADS) Depression and Anxiety Symptoms Subscales Between Baseline and Week 21. |
Change in total HADS score between Baseline and Week 21. Each of the 14 items is scored 0, 1, 2 or 3 where a score of 3 corresponds to the most anxious/depressed. 7-item depression and 7-item anxiety subscales are summed; each resulting in a total score of 0-21. |
Baseline, End of 21-week treatment |
|
Secondary |
Number of Subjects With a Weight Gain at End of Treatment of at Least 7% Relative to Baseline |
Count of subjects with a weight gain of at least 7 percent relative to baseline. |
Baseline, End of 21-week treatment |
|
Secondary |
Subjects Assessment of Optimal Sleep |
Number of subjects that responded optimal or non-optimal sleep in Optimal Sleep subscale of Medical Outcomes Study (MOS) Sleep scale. |
Baseline, End of 21-week treatment |
|