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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Athens | 11526 | Greece | |||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Single arm open label study without randomization. The study included the following 3 main phases with a total study treatment duration of up to 21 weeks: Treatment dose-optimization phase = 9 weeks. Treatment observation phase = 12 weeks.
Planned to enroll approximately 100 subjects with partial seizures at up to 10 study centers in Greece.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin | Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin | Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). Seizure rate was calculated on last observation carried forward (LOCF) basis, whereby data from last 84 days prior to last dose was used to calculate seizure frequency. | Posted | Median | Full Range | percentage change in events | 8 week baseline period & 12 week treatment observation period |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pregabalin | Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lower Limb Fracture | Injury, poisoning and procedural complications | MedDRAv11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA v11.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| 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 |
| Number of Subjects Seizure-free | Count of subjects seizure free during the period. | 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. | 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. | 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. | 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). | 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). | 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. | 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. | 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. | 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. | Baseline, End of 21-week treatment |
| Athens |
| 11527 |
| Greece |
| Pfizer Investigational Site | Heraklio | 71110 | Greece |
| Pfizer Investigational Site | Mesogion, Athen | 15125 | Greece |
| Pfizer Investigational Site | Pátrai | 26500 | Greece |
| Pfizer Investigational Site | Thessaloniki | 54636 | Greece |
| Pfizer Investigational Site | Thessaloniki | 57010 | Greece |
| Pfizer Investigational Site | Thessaloniki | Greece |
| Other |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (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. | Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). Seizure rate was calculated on last observation carried forward (LOCF) basis, whereby data from last 84 days prior to last dose was used to calculate seizure frequency. | Posted | Median | Full Range | percentage change in events | 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. | Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). Seizure date from patients who discontinued during any of these 4 week intervals will not be included in the summary for that interval. | Posted | Median | Full Range | percentage change of events | 8 week baseline period and 21 week treatment period |
|
|
|
|
| Post-Hoc | Change in Partial Seizure Frequency by Type Between the 8 Week Baseline Period and During the 12 Week Observation Period. | Change from baseline = 12 week treatment observation period seizure frequency rate minus 8 week baseline period seizure frequency rate. | Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). Seizure rate was calculated on last observation carried forward (LOCF) basis, whereby data from last 84 days prior to last dose was used to calculate seizure frequency. | Posted | Median | Full Range | change in median partial seizures | 8 week baseline period & 12 week treatment observation period |
|
|
|
|
| Secondary | Number of Subjects Seizure-free | Count of subjects seizure free during the period. | Full analysis set(FAS)/intent-to-treat(ITT) all subjects who received >= 1 dose of study Tx & >= 2 partial seizures during baseline pd. LOCF if subjects withdrew then last 4 wks prior to last dose (but after visit 3). 12 wk subjects who withdrew were regarded as missing. n= # subjects evaluable for seizure freedom during defined observation pd. | Posted | Number | participants | 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. | Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). Patients who discontinued less than 4 weeks into the observation period (after Visit 3/week 9) will be regarded as missing. No data prior to week 9 will be used. | Posted | Number | participants | 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. | Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). | Posted | Number | participants | 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. | Full analysis set (FAS)/intent-to-treat (ITT) (all subjects who received at least 1 dose of study treatment & minimum 2 partial seizures during baseline pd). Seizure rate was calculated on last observation carried forward (LOCF) basis, whereby data from last 84 days prior to last dose was used to calculate seizure frequency. | Posted | Median | Full Range | percentage change in events | 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). | Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment and had a minimum of 2 partial seizures during the baseline period). | Posted | Number | participants | 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). | Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment and had a minimum of 2 partial seizures during the baseline period). | Posted | Number | partcipants | 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. | Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). "n" is the number of subjects contributing to the mean at the specified time point. | Posted | Mean | 95% Confidence Interval | score on scale | 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. | Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). "n" is the number of subjects contributing to the mean at the specified time point. | Posted | Mean | 95% Confidence Interval | score on scale | 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. | Safety population (all subjects who had taken at least 1 dose of study drug). | Posted | Number | participants | 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. | Full analysis set (FAS)/intent-to-treat (ITT) population (all subjects who received at least 1 dose of study treatment & had a minimum of 2 partial seizures during baseline period). | Posted | Number | participants | Baseline, End of 21-week treatment |
|
|
|
| 3 |
| 35 |
| Balance Disorder | Nervous system disorders | MedDRA v11.1 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA v11.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA v11.1 | Systematic Assessment |
|
| Weight Increased | Investigations | MedDRA v11.1 | Systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA v11.1 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA v11.1 | Systematic Assessment |
|
| Disturbance in Attention | Nervous system disorders | MedDRA v11.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v11.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v11.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA v11.1 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA v11.1 | Systematic Assessment |
|
| Gait Disturbance | General disorders | MedDRA v11.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA v11.1 | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of <60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), <12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| Title | Measurements |
|---|---|
|
| 85-112 Days |
|
| 113-140 Days |
|
| >140 Days |
|
| Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power,true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed. | Mean Response Ratio | -22.83 | Standard Deviation | 57.543 | 95 | -34.74 | -10.91 | 29-56 Days. Response ratio = 100 x [(t - b)/(t + b)] where t= 4 wk interval seizure frequency and b=baseline seizure frequency. | Superiority or Other (legacy) |
| Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed. | Mean Response Ratio | -27.18 | Standard Deviation | 59.323 | 95 | -39.90 | -14.46 | 57-84 Days. Response ratio = 100 x [(t - b)/(t + b)] where t= 4 wk interval seizure frequency and b=baseline seizure frequency. . | Superiority or Other (legacy) |
| Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%.Allowing for dropouts assume 85% pts analyzed. | Mean Response Ratio | -30.75 | Standard Deviation | 58.110 | 95 | -43.44 | -18.06 | 85-112 Days. Response ratio=100 x [(t - b)/(t + b)] where t= 4 wk interval seizure frequency and b=baseline seizure frequency. | Superiority or Other (legacy) |
| Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%.Allowing for dropouts assume 85% pts analyzed. | Mean Response Ratio | -38.75 | Standard Deviation | 59.368 | 95 | -51.79 | -25.70 | 113-140 Days. Response ratio=100 x [(t - b)/(t + b)] where t= 4 wk interval seizure frequency and b=baseline seizure frequency. | Superiority or Other (legacy) |
| Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power,true change from baseline approximately 25%.Allowing for dropouts assume 85% pts analyzed. | Mean Response Ratio | -44.24 | Standard Deviation | 62.703 | 95 | -58.47 | -30.01 | >140 Days. Response ratio= 100 x [(t - b)/(t + b)] where t= 4 wk interval seizure frequency and b=baseline seizure frequency. | Superiority or Other (legacy) |
|
| Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed. | Mean Response Ratio | -22.24 | Standard Deviation | 68.058 | 95 | -37.80 | -6.69 | Complex Partial Seizures. Response ratio = 100 x [(t - b)/(t + b)] where t=treatment seizure frequency and b=baseline seizure frequency. | Superiority or Other (legacy) |
| Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed. | Mean Response Ratio | -23.85 | Standard Deviation | 84.313 | 95 | -55.33 | 7.64 | Evolved to Generalized. Response ratio = 100 x [(t - b)/(t + b)] where t=treatment seizure frequency and b=baseline seizure frequency. | Superiority or Other (legacy) |
| Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed. | Mean Response Ratio | -20.78 | Standard Deviation | 50.334 | 95 | -35.24 | -6.33 | Seizure freq. >3 / 28 d. Resp. ratio = 100 x [(t - b)/(t + b)] where t=treatment seizure frequency and b=baseline seizure frequency. | Superiority or Other (legacy) |
| Title | Measurements |
|---|---|
|
| No Change |
|
| Minimally Worse |
|
| Much Worse |
|
| Very Much Worse |
|
| Missing / Not Done |
|
| Title | Measurements |
|---|---|
|
| No Change |
|
| Minimally Worse |
|
| Much Worse |
|
| Very Much Worse |
|
| Missing / Not Done |
|
|
| Quantity of Sleep (n=66) |
|
| Sleep Adequacy (n=77) |
|
| Somnolence (n=77) |
|
| Sleep Problems Index (n=72) |
|
| Title | Measurements |
|---|---|
|
| Weight gain ≥20% |
|
| Title | Measurements |
|---|---|
|
| Non-Optimal Sleep Baseline, Non-Optimal Sleep Wk21 |
|