The objective of study is to assess the clinical improvement (change in seizure frequency), safety, and tolerability of subjects with partial seizures following adjunctive therapy of pregabalin BID (150 to 600 mg/day titration) in addition to existing standards AEDs.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
98
Pregabalin treatment, given as 2 divided doses, is initiated at a dose of 150 mg/day (75 mg BID). Based on individual subject response and tolerability, the dosage may be increased to 300 mg/day after 1 week (150 mg BID given as two 75-mg capsules BID). Based on subjects individual response and tolerability, dosage can be incrementally increased further after an additional week to 600 mg/day (300 mg BID given as four 75-mg capsules BID).
Pfizer Investigational Site
Athens, Greece
Pfizer Investigational Site
Athens, Greece
Pfizer Investigational Site
Heraklio, Greece
Pfizer Investigational Site
Mesogion, Athen, Greece
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).
Time frame: 8 week baseline period & 12 week treatment observation period
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.
Time frame: 8 week baseline period and 21 week treatment period
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.
Time frame: 8 week baseline period and 21 week treatment period
Number of Subjects Seizure-free
Count of subjects seizure free during the period.
Time frame: last 4 weeks & whole 12 week treatment observation period
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.
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Pfizer Investigational Site
Pátrai, Greece
Pfizer Investigational Site
Thessaloniki, Greece
Pfizer Investigational Site
Thessaloniki, Greece
Pfizer Investigational Site
Thessaloniki, Greece
Time frame: 8 week baseline observation period & last 4 weeks of observation period
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.
Time frame: Day 147 from the first dose of study drug
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.
Time frame: 8 week baseline observation period & 12 week treatment observation period
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).
Time frame: End of 21-week treatment
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).
Time frame: End of 21-week treatment
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.
Time frame: Baseline, end of 21-week treatment
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.
Time frame: Baseline, End of 21-week treatment
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.
Time frame: Baseline, End of 21-week treatment
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.
Time frame: Baseline, End of 21-week treatment