| Primary | Percent Change in the 28-day Total Partial Seizure (PS) Frequency From Baseline (BL) to the End of the Double-blind (DB) Phase (Titration and Maintenance Phases) | 28-day total PS (PSs [also called focal seizures] are seizures limited to a specific area of the brain) frequency in the BL period = (Number [No.] of total PSs reported in the BL period divided by the No. of days of available total PS data in the BL period) x 28 days. 28-day total PS frequency in the DB period = (No. of total PSs reported in the DB period divided by the No. of days of available total PS data in the DB period) x 28 days. Percent change = ([value in the DB period minus value at BL] divided by the BL value) x 100%. Negative values indicate a reduction in seizure frequency. | Intent-to-Treat (ITT) Population for Food and Drug Administration (FDA) review: all randomized participants (par.) who received at least one dose of the study drug. Only par. with baseline and post-baseline measures were analyzed. Two par. in each treatment arm did not have post-baseline measures and were thus not included in this analysis. | Posted | | Median | Full Range | percent change in seizure frequency | | Baseline (Week -7 through Week 0), Week 1 through Week 18 | | | | ID | Title | Description |
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| OG000 | Placebo - DB Phase (Titration + Maintenance) | Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase) | | OG001 | Retigabine - DB Phase (Titration + Maintenance) | Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day]) |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-17.5(-90 to 628)
- OG001-44.3(-100 to 302)
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Non-parametric rank ANCOVA | | <0.001 | Non-parametric rank analysis of covariance adjusted for baseline 28-seizure frequency and stratified by baseline seizure frequency category and region | | | | | | 95 | | | | | | No | Superiority or Other | | |
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| Primary | Number of Participants Who Were Responders and Non-responders in the Maintenance Phase | Responders were participants with at least a 50% reduction in the 28-day total partial seizure frequency in the Maintenance Phase as compared to the Baseline period. | Intent-to-Treat (ITT) Population for European Medicines Agency (EMEA) review: all randomized participants who received at least one dose of study drug in the Maintenance Phase and had at least one seizure measurement (whether or not they had a seizure) recorded in the Maintenance Phase | Posted | | Number | | participants | | Week 7 through Week 18 | | | | ID | Title | Description |
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| OG000 | Placebo - Maintenance Phase | Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks | | OG001 | Retigabine - Maintenance Phase | Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day]) |
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| Secondary | Number of Participants Who Were Responders and Non-responders in the DB Phase | Responders were participants with at least a 50% reduction in the 28-day total partial seizure frequency in the DB Phase as compared to the Baseline period. Participants without any post-baseline data were considered non-responders. | ITT Population for FDA review | Posted | | Number | | participants | | Week 1 through Week 18 | | | | ID | Title | Description |
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| OG000 | Placebo - DB Phase (Titration + Maintenance) | Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase) | | OG001 | Retigabine - DB Phase (Titration + Maintenance) | Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day]) |
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| Secondary | Percent Change From Baseline (BL) in the 28-day Total Partial Seizure Frequency During the Maintenance Phase | 28-day total partial seizure frequency in the BL period = (No. of total partial seizures reported in the BL period divided by the No. of days of available total partial seizure data in the BL period) x 28 days. 28-day total partial seizure frequency in the Maintenance Phase = (No. of total partial seizures reported in the Maintenance Phase divided by the No. of days of available total partial seizure data in the same phase) x 28 days. Percent change = (value in the Maintenance Phase minus value at BL divided by the BL value) x 100%. Negative values indicate a reduction in seizure frequency. | ITT Population for EMEA review | Posted | | Median | Full Range | percent change in seizure frequency | | Baseline (Week -7 through Week 0), Week 7 through Week 18 | | | | ID | Title | Description |
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| OG000 | Placebo - Maintenance Phase | Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks | | OG001 | Retigabine - Maintenance Phase | Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID), for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day]) |
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| Secondary | Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the End of DB Phase (Titration and Maintenance Phases) by Indicated Quartile Reduction Categories | Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized as having a reduction of 75-100%, 50-<75%, 25-<50%, or <25%, in addition to having no reduction. This quartile cutting was specified in the study protocol. Participants without any post-baseline data were included in the "No reduction" category. | ITT Population for FDA review | Posted | | Number | | participants | | Baseline (Week -7 through Week 0), Week 1 through Week 18 | | | | ID | Title | Description |
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| OG000 | Placebo - DB Phase (Titration + Maintenance) | Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase) | | OG001 | Retigabine DB Phase (Titration + Maintenance) | Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day]) |
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| Secondary | Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the End of the DB Phase (Titration and Maintenance Phases) by Indicated Decile Reduction and Increase Categories | Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized in decile cutting, i.e., reduction categories of 90-100%, 80-<90%, 70-<80%, 60-<70%, 50-<60%, 40-<50%, 30-<40%, 20-<30%, 10-<20%, >0-<10%, and increase categories of 0-10%, >10-20%, >20-30%, >30% (FDA endpoint). Participants without any post-baseline data were included in the 0-10% increase category. | ITT Population for FDA review | Posted | | Number | | participants | | Baseline (Week -7 through Week 0), Week 1 through Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Placebo - DB Phase (Titration + Maintenance) | Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase) | | OG001 | Retigabine DB Phase (Titration + Maintenance) | Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day]) |
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| Secondary | Number of Participants With the Indicated Reduction From Baseline in the 28-day Total Partial Seizure Frequency During the Maintenance Phase | Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized as having a >75%, a 50-75%, or a <50% reduction, in addition to having no reduction (EMEA endpoint). | ITT Population for EMEA review | Posted | | Number | | participants | | Baseline (Week -7 through Week 0), Week 7 through Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Placebo - Maintenance Phase | Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks | | OG001 | Retigabine - Maintenance Phase | Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day]) |
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| Secondary | Number of Participants Who Experienced the Indicated Level of Exacerbation and Reduction in the 28-day Total Partial Seizure Frequency From Baseline During the Maintenance Phase | Participants who experienced an exacerbation from Baseline in the 28-day total partial seizure frequency were categorized as having a 0-25% or a >25% increase (EMEA endpoint). The number of participants experiencing a >0% reduction from Baseline in the 28-day total partial seizure frequency are also presented. | ITT Population for EMEA review. | Posted | | Number | | participants | | Baseline (Week -7 through Week 0), Week 7 through Week 18 | | | | ID | Title | Description |
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| OG000 | Placebo - Maintenance Phase | Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks | | OG001 | Retigabine - Maintenance Phase | Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day]) |
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| Secondary | Number of Participants Reporting New Seizure Types in the Indicated Categories During the DB Phase (Titration and Maintenance Phases) That Were Not Reported at Baseline | New seizure types included those seizures which were not reported by any participant at Baseline. | ITT Population for FDA review | Posted | | Number | | participants | | Baseline (Week -7 through Week 0), Week 1 through Week 18 | | | | ID | Title | Description |
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| OG000 | Placebo - DB Phase (Titration + Maintenance) | Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase) | | OG001 | Retigabine DB Phase (Titration + Maintenance) | Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day]) |
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| Secondary | Number of Participants Who Were Seizure-free During the DB Phase (Titration and Maintenance Phases) | Participants were considered to be seizure-free if they had not reported any seizures during the DB treatment period (Weeks 1-18). For a participant to be seizure free during the DB Phase, the participant had to be seizure free both Week 7 to Week 18 and Week 1 to Week 6. A participant could be seizure free Week 7 to Week 18 (during the Maintenance Phase), but not seizure free Week 1 to Week 6. Hence, there are fewer participants being reported as seizure free from Week 1 to Week 18 than from Week 7 to Week 18. | ITT Population for FDA review. Only participants who had post-baseline seizure data were included in the analysis. | Posted | | Number | | participants | | Week 1 through Week 18 | | | | ID | Title | Description |
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| OG000 | Placebo - DB Phase (Titration + Maintenance) | Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase) | | OG001 | Retigabine DB Phase (Titration + Maintenance) | Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day]) |
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| Secondary | Number of Participants Who Were Seizure-free During the Maintenance Phase | Participants were considered to be seizure-free if they had not reported any seizures during the Maintenance Phase. | ITT Population for EMEA review | Posted | | Number | | participants | | Week 7 through Week 18 | | | | ID | Title | Description |
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| OG000 | Placebo - Maintenance Phase | Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks | | OG001 | Retigabine - Maintenance Phase | Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day]) |
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| Secondary | Percentage of Seizure-free Days During the DB Phase (Titration and Maintenance Phases) | A seizure-free day was a day without any seizures. For a participant to be seizure free during the DB Phase, the participant had to be seizure free both Week 7 to Week 18 and Week 1 to Week 6. A participant could be seizure free Week 7 to Week 18 (during the Maintenance Phase), but not seizure free Week 1 to Week 6. Hence, there are fewer participants being reported as seizure free from Week 1 to Week 18 than from Week 7 to Week 18. The percentage of seizure-free days was calculated as the total number of days without seizures in the DB period divided by the number of days in DB period x 100%. | ITT Population for FDA review. Only participants who had post-baseline seizure data were included in the analysis. | Posted | | Median | Full Range | percentage of days | | Week 1 through Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Placebo - DB Phase (Titration + Maintenance) | Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase) | | OG001 | Retigabine DB Phase (Titration + Maintenance) | Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day]) |
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| Secondary | Percentage of Seizure-free Days During the Maintenance Phase | A seizure-free day was a day without any seizures. The percentage of seizure-free days was calculated as the total number of days without seizures in the DB period divided by the number of days in the DB period x 100%. | ITT Population for EMEA review | Posted | | Median | Full Range | percentage of days | | Week 7 through Week 18 | | | | ID | Title | Description |
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| OG000 | Placebo - Maintenance Phase | Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks | | OG001 | Retigabine - Maintenance Phase | Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day]) |
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| Secondary | Clinical Global Impression-Improvement (CGI-I) Score at the End of the Maintenance Phase | Clinical Global Impression of Improvement (CGI-I) is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the treatment. Scores on the scale are rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. | ITT Population for EMEA review. Only participants who had CGI-I scores were analyzed. | Posted | | Mean | Standard Deviation | scores on a scale | | Week 18/end of treatment phase | | | | ID | Title | Description |
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| OG000 | Placebo - Maintenance Phase | Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks | | OG001 | Retigabine - Maintenance Phase | Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day]) |
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| Secondary | Patient Global Impression (PGI) Score at the End of the Maintenance Phase | PGI is a participant-rated scale of improvement that was administered at the end of the Maintenance Phase in order to assess the participant's impression of his or her own improvement. PGI assessments were scored using a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. | ITT Population for EMEA review. Only participants who had a PGI score were analyzed. | Posted | | Mean | Standard Deviation | scores on a scale | | Week 18/end of treatment phase | | | | ID | Title | Description |
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| OG000 | Placebo - Maintenance Phase | Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks | | OG001 | Retigabine - Maintenance Phase | Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day]) |
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| Secondary | Quality of Life (QOL) Assessed by QOL in Epilepsy-Problems Questionnaire (QOLIE-31-P) at Baseline (Week 0) and Weeks 6, 10, and 18 | The QOLIE-31-P is a 31-item questionnaire evaluating a participant's QOL perception in 7 domains: seizure worry, emotional well being, energy/fatigue, cognitive functioning, medication effects, social functioning, overall QOL. Precoded numeric values for some domains are such that a higher number reflects a more favorable health state; others are such that a higher number reflects a less favorable state. Precoded values are first converted to 0-100 point scores; higher converted scores always reflect better QOL. The overall score is derived by weighting and then summing the 7 domain scores. | Safety Population: all randomized participants who received at least 1 dose of retigabine or placebo. Participants who were cognitively impaired and could not complete the QOLIE-31-P assessment were not analyzed. The number of participants analyzed differs by week because not all participants completed the questionnaire at the indicated weeks. | Posted | | Mean | Standard Deviation | scores on a scale | | End of Baseline (Week 0), Weeks 6, 10, and 18 | | | | ID | Title | Description |
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| OG000 | Placebo - DB Phase (Titration + Maintenance) | Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase) | | OG001 | Retigabine DB Phase (Titration + Maintenance) | |
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| Secondary | Number of Participants Whose Clinical Laboratory Values Were Deemed an Adverse Event by the Investigator (>=2% in Any Treatment Arm) | Clinically important changes in laboratory values were to be reported as an adverse event if they met one of the following criteria: (1) intervention required; (2) change in dose of study drug required; (3) other treatment/therapy required; (4) association with other diagnoses. | | Posted | | Number | | participants | | Week 1 through Week 24 | | | | ID | Title | Description |
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| OG000 | Placebo - DB Phase (Titration and Maintenance) | Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase) | | OG001 | Placebo (DB Phase) and Retigabine (Transition Phase) | Participants on placebo during the DB phase were administered retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a total daily dose of 1200 mg/day (400 mg TID) for 6 weeks | | OG002 | Retigabine - DB Phase (Titration and Maintenance) | Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of the Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of the Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day]) |
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| Secondary | Number of Participants Who Reported the Indicated Renal and Urinary Disorder Adverse Events at a Frequency Threshold of 2% (in Any Treatment Arm) | A summary of the adverse events classified as renal or urinary disorders and in which at least 2% (rounded to an integer) of participants in any treatment arm reported during the study is presented. | | Posted | | Number | | participants | | Week 1 through Week 24 | | | | ID | Title | Description |
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| OG000 | Placebo - DB Phase (Titration and Maintenance) | Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase) | | OG001 | Placebo (DB Phase) and Retigabine (Transition Phase) | Participants on placebo during the DB phase were administered retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a total daily dose of 1200 mg/day (400 mg TID) for 6 weeks | | OG002 | Retigabine - DB Phase (Titration and Maintenance) | Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day]) |
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| Secondary | Change From Baseline in Post-void Residual Urine Volume at Weeks 10 and 18 of the DB Treatment Phase | Post-void residual (PVR) urine refers to the amount of urine remaining in the bladder after normal urination. To investigate the possible effects of retigabine on bladder function, all participants underwent post-void residual bladder ultrasound at Baseline and during the Maintenance Phase. The PVR bladder ultrasound was performed by a urologist, a qualified ultrasound technician, or a qualified study nurse who was certified to do PVR bladder ultrasound. Change from Baseline in PVR residual volume was calculated as the values at Week 10 and Week 18 minus the value at Baseline. | Safety Population. Only participants who remained in the study at the indicated week and who also had a PVR assessment were analyzed. | Posted | | Median | Full Range | milliliters | | Baseline (Week -7 through Week 0), Weeks 10 and 18 | | | | ID | Title | Description |
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| OG000 | Placebo - DB Phase (Titration and Maintenance) | Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase) | | OG001 | Retigabine - DB Phase (Titration and Maintenance) | Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day]) |
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| Secondary | Number of Participants With a >=7% Increase in Body Weight During Weeks 2, 4, and 6 of theTitration Phase and Weeks 7, 8, 10, 14, and 18 of the Maintenance Phase | The number of participants with recorded weight gain of >=7% over their baseline weight was measured. | Safety Population. Only participants who remained in the study at the indicated week and who also had a body weight assessment were analyzed. | Posted | | Number | | participants | | Weeks 2, 4, 6 of Titration Phase and Weeks 7, 8, 10, 14, and 18 of Maintenance Phase | | | | ID | Title | Description |
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| OG000 | Placebo - DB Phase (Titration + Maintenance) | Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase) | | OG001 | Retigabine DB Phase (Titration + Maintenance) | Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day]) |
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