| Primary | 50 Percent (%) Responder Rate for Partial Onset Seizure With or Without Secondary Generalization | The 50% responder rate was defined as the percentage of participants who achieved at least 50% reduction from baseline in the frequency of partial onset seizure with or without secondary generalization during the Maintenance Period. | The full analysis set included participants who received at least one dose of investigational product and were assessed for primary efficacy at least once after study treatment. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline up to Week 36 | | | | ID | Title | Description |
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| OG000 | Perampanel 12 mg | During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg according to the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to Week 36. At the discretion of investigators, dose adjustments were allowed based on the participant's clinical response and tolerability. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00080.0(69.92 to 87.90)
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| Secondary | 75% Responder Rate for Partial Onset Seizure With or Without Secondary Generalization | The 75% responder rate was defined as the percentage of participants who achieved at least 75% reduction from baseline in the frequency of partial onset seizure with or without secondary generalization during the Maintenance Period. | The full analysis set included participants who received at least one dose of investigational product and were assessed for primary efficacy at least once after study treatment. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline up to Week 36 | | | | ID | Title | Description |
|---|
| OG000 | Perampanel 12 mg | During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg according to the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to Week 36. At the discretion of investigators, dose adjustments were allowed based on the participant's clinical response and tolerability. |
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| Secondary | 100% Responder Rate (Seizure Free Rate) for Partial Onset Seizure With or Without Secondary Generalization | The 100% responder rate was defined as the percentage of participants who achieved at least 100% reduction from baseline in the frequency of partial onset seizure with or without secondary generalization during the Maintenance Period. | The full analysis set included participants who received at least one dose of investigational product and were assessed for primary efficacy at least once after study treatment. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline up to Week 36 | | | | ID | Title | Description |
|---|
| OG000 | Perampanel 12 mg | During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg according to the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to Week 36. At the discretion of investigators, dose adjustments were allowed based on the participant's clinical response and tolerability. |
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| Secondary | Percent Change From Baseline in Partial Onset Seizure Frequency With or Without Secondary Generalization to the Titration and Maintenance Period | Percent change in the frequency of partial onset seizure with or without secondary generalization was defined as the percent reduction in seizure frequency from baseline to titration period and maintenance period. Percent change from Baseline was calculated as: ([post-Baseline value minus the Baseline value] / Baseline value)*100. A negative percent change from baseline indicates a decrease in partial seizure frequency. | The full analysis set included participants who received at least one dose of investigational product and were assessed for primary efficacy at least once after study treatment. Participants who were evaluable for this given measure at a given time point were included for this assessment. | Posted | | Median | Full Range | percent change | | Weeks 12 and 36 | | | | ID | Title | Description |
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| OG000 | Perampanel 12 mg | During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg according to the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to Week 36. At the discretion of investigators, dose adjustments were allowed based on the participant's clinical response and tolerability. |
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| Secondary | 50% Responder Rate in Secondary Generalized Tonic Clonic (GTC) Seizures | The 50% responder rate was defined as the percentage of participants who have achieved at least a 50% reduction from baseline in the frequency of secondary GTC seizure during the Maintenance Period. GTC seizures are defined as seizures involved with generalized stiffening and rhythmic jerking of the limbs, caused by bilateral malfunction of the brain. | The full analysis set included participants who received at least one dose of investigational product and were assessed for primary efficacy at least once after study treatment. Participants who were evaluable for this given measure at a given time point were included for this assessment. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline up to Week 36 | | | | ID | Title | Description |
|---|
| OG000 | Perampanel 12 mg | During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg according to the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to Week 36. At the discretion of investigators, dose adjustments were allowed based on the participant's clinical response and tolerability. |
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| Secondary | 75% Responder Rate in Secondary GTC Seizures | The 75% responder rate was defined as the percentage of participants who achieved at least a 75% reduction from baseline in seizure frequency of secondary GTC seizure during the Maintenance Period. GTC seizures are defined as seizures involved with generalized stiffening and rhythmic jerking of the limbs, caused by bilateral malfunction of the brain. | The full analysis set included participants who received at least one dose of investigational product and were assessed for primary efficacy at least once after study treatment. Participants who were evaluable for this given measure at a given time point were included for this assessment. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline up to Week 36 | | | | ID | Title | Description |
|---|
| OG000 | Perampanel 12 mg | During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg according to the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to Week 36. At the discretion of investigators, dose adjustments were allowed based on the participant's clinical response and tolerability. |
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| Secondary | 100% Responder Rate (Seizure Free Rate) in Secondary GTC Seizures | The 100% responder rate was defined as the percentage of participants who have at least a 100% reduction from baseline in the frequency of secondary GTC seizures during the Maintenance Period. GTC seizures are defined as seizures involved with generalized stiffening and rhythmic jerking of the limbs, caused by bilateral malfunction of the brain. | The full analysis set included participants who received at least one dose of investigational product and were assessed for primary efficacy at least once after study treatment. Participants who were evaluable for this given measure at a given time point were included for this assessment. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline up to Week 36 | | | | ID | Title | Description |
|---|
| OG000 | Perampanel 12 mg | During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg according to the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to Week 36. At the discretion of investigators, dose adjustments were allowed based on the participant's clinical response and tolerability. |
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| Secondary | Percent Change From Baseline in Secondary GTC Seizure Frequency to the Titration and Maintenance Period | Percent change in the frequency of secondary GTC seizure was defined as the percent reduction in seizure frequency from baseline to Titration Period and Maintenance Period. GTC seizures are defined as seizures involved with generalized stiffening and rhythmic jerking of the limbs, caused by bilateral malfunction of the brain. Percent change from Baseline was calculated as: ([post-Baseline value minus the Baseline value] / Baseline value)*100. A negative percent change from baseline indicates a decrease in partial seizure frequency. | The full analysis set included participants who received at least one dose of investigational product and were assessed for primary efficacy at least once after study treatment. Participants who were evaluable for this given measure at a given time point were included for this assessment. | Posted | | Median | Full Range | percent change | | Weeks 12 and 36 | | | | ID | Title | Description |
|---|
| OG000 | Perampanel 12 mg | During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg according to the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to Week 36. At the discretion of investigators, dose adjustments were allowed based on the participant's clinical response and tolerability. |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | | The safety set included participants who received at least one dose of investigational product and were assessed for safety at least once after study treatment. | Posted | | Count of Participants | | Participants | No | From the first dose of investigational product to the last visit or 28 days after the last dose (up to 1 year 11 months) | | | | ID | Title | Description |
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| OG000 | Perampanel 12 mg | During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg according to the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to Week 36. At the discretion of investigators, dose adjustments were allowed based on the participant's clinical response and tolerability. |
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