Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To confirm that the combination therapy of rufinamide has superior efficacy compared to placebo in patients with Lennox-Gastaut syndrome.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rufinamide (E2080) | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rufinamide (E2080) | Drug | Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Tonic-Atonic Seizure Frequency From Baseline (Per 28 Days) | The sum of the frequencies of tonic seizures and atonic seizures was defined as the "tonic-atonic seizure frequency" and the percent change in tonic-atonic seizure frequency per 28 days was assessed. The percent change in tonic-atonic seizure frequency was calculated using the tonic-atonic seizure frequency per 28 days of the Observation Period as the baseline and the tonic-atonic seizure frequency per 28 days of the Treatment Period as the post-treatment value. Percentage change in tonic - atonic seizure frequency was calculated as follows: [100 x (post-treatment value - baseline)/ baseline]. The frequency of epileptic seizures was recorded in the seizure diary by the recorder. Seizure frequency was counted based on the classification established by the International League Against Epilepsy (ILAE). The diary recorder monitored the participant and recorded the seizure diary in a consistent manner, and continued these practices throughout the study period. | Baseline (28 day observational period) and End of Treatment (28 day treatment period) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Achieving a 50% Reduction in Tonic-atonic Seizure Frequency | 50% Responder Rate in Tonic-Atonic Seizure Frequency was presented as the number of participants who achieved a 50% reduction in tonic-atonic seizure frequency. | 12 weeks |
| Percent Change in Total Seizure Frequency (Per 28 Days) |
Not provided
Inclusion criteria
Exclusion criteria;
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hiroki Takano | Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya | Aichi-ken | Japan | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33825230 | Derived | Brigo F, Jones K, Eltze C, Matricardi S. Anti-seizure medications for Lennox-Gastaut syndrome. Cochrane Database Syst Rev. 2021 Apr 7;4(4):CD003277. doi: 10.1002/14651858.CD003277.pub4. | |
| 33179247 | Derived | Panebianco M, Prabhakar H, Marson AG. Rufinamide add-on therapy for drug-resistant epilepsy. Cochrane Database Syst Rev. 2020 Nov 8;11(11):CD011772. doi: 10.1002/14651858.CD011772.pub3. |
Not provided
Not provided
Of n= 66 who started Observation Period, 7 discontinued from study. Primary reasons were deviation of the inclusion/ exclusion criteria (n=5), untoward event before study treatment (n=1) & other (n=1). Of 59 participants, 58 were included in full analysis set (FAS). 1 participant (E2080 group) was excluded due to inappropriate diagnosis of disease.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Rufinamide (E2080) | Rufinamide : Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Placebo | Drug | Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks. |
|
Percent change in the total seizure frequency (per 28 days) was calculated using the total seizure frequency per 28 days of the Observation Period as the baseline and the total seizure frequency per 28 days of the Treatment Period as the post-treatment value. Percentage change in total seizure frequency was calculated as follows: [100 x (post-treatment value - baseline)/ baseline]. |
| Baseline (28 day observational period) and End of Treatment (28 day treatment period) |
| Percentage Change in the Frequency of Seizures Other Than Tonic-atonic Seizures (Per 28 Days) | Percent change in the frequency of seizures other than tonic-atonic seizures (per 28 days) was calculated using the total seizure frequency per 28 days of the Observation Period as the baseline and the total seizure frequency per 28 days of the Treatment Period as the post-treatment value. Percentage change in total seizure frequency was calculated as follows: [100 x (post-treatment value - baseline)/ baseline]. Seizures analyzed other than tonic-atonic seizures included: Partial seizure freq. (frequency), Absence seizure, Atyp. (atypical) absence seizure, Myoclonic seizure, Clonic seizure, Tonic seizure, Tonic-clonic seizure, Atonic seizure, & Uncla. (unclassified) epileptic seizure. The frequency of epileptic seizures was recorded in the diary by the recorder. Seizure frequency was counted based on the classification established by the International League Against Epilepsy (ILAE). The diary recorder monitored the participant and recorded the seizure diary in a consistent manner. | Baseline (28 day observational period) and End of Treatment (28 day treatment period) |
| Clinical Global Impression of Change (CGIC) | CGIC in participants with Lennox-Gastaut Syndrome (LGS) relative to placebo was presented as number of participants in each category at the final assessment (last observation carried forward [LOCF]) & at Week 12 of the Treatment Period. The investigator assessed the CGIC by comparing the participants' condition during the 4 weeks immediately before the completion (or discontinuation [d/c]) of the Treatment Period to his/her condition during the 4-week Observation Period (for participants who d/c'd the study during the Treatment Period, the CGIC was assessed by comparing the participant's condition from the start to discontinuation of the study treatment to his/her condition during the 4-week Observation Period). The CGIC was assessed according to the following 7-grade scale based on the frequency & severity of seizures, AEs, and overall conditions of daily life. Markedly improved, Improved, Slightly improved, Unchanged, Slightly worsened, Worsened, Markedly worsened. | Up to Week 12 of the treatment period |
| Matsuyama |
| Ehime |
| Japan |
| Fukuoka | Fukuoka | Japan |
| Hiroshima | Hiroshima | Japan |
| Sapporo | Hokkaido | Japan |
| Kobe | Hyōgo | Japan |
| Yokohama | Kanagawa | Japan |
| Goshi-shi | Kumamoto | Japan |
| Iwamuma-shi | Miyagi | Japan |
| Omura-shi | Nagasaki | Japan |
| Nara | Nara | Japan |
| Niigata | Niigata | Japan |
| Yufu-shi | Oita Prefecture | Japan |
| Okayama | Okayama-ken | Japan |
| Neyagawa | Osaka | Japan |
| Osaka | Osaka | Japan |
| Suita-shi | Osaka | Japan |
| Moriya-shi | Shiga | Japan |
| Shizuoka | Shizuoka | Japan |
| Kodaira-shi | Tokyo | Japan |
| Kokubunji-shi | Tokyo | Japan |
| Shinjuku-ku | Tokyo | Japan |
| Toyoma-shi | Toyama | Japan |
| FG001 | Placebo | Placebo : Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
One subject from the Rufinamide (E2080) group was excluded from the FAS because of the inappropriate diagnosis of the disease, dropping the total number from 29 to 28 participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rufinamide (E2080) | Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening) |
| BG001 | Placebo | Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Percent Change in Tonic-Atonic Seizure Frequency From Baseline (Per 28 Days) | The sum of the frequencies of tonic seizures and atonic seizures was defined as the "tonic-atonic seizure frequency" and the percent change in tonic-atonic seizure frequency per 28 days was assessed. The percent change in tonic-atonic seizure frequency was calculated using the tonic-atonic seizure frequency per 28 days of the Observation Period as the baseline and the tonic-atonic seizure frequency per 28 days of the Treatment Period as the post-treatment value. Percentage change in tonic - atonic seizure frequency was calculated as follows: [100 x (post-treatment value - baseline)/ baseline]. The frequency of epileptic seizures was recorded in the seizure diary by the recorder. Seizure frequency was counted based on the classification established by the International League Against Epilepsy (ILAE). The diary recorder monitored the participant and recorded the seizure diary in a consistent manner, and continued these practices throughout the study period. | Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below. Participants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment. | Posted | Median | Full Range | Percent Change | Baseline (28 day observational period) and End of Treatment (28 day treatment period) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Achieving a 50% Reduction in Tonic-atonic Seizure Frequency | 50% Responder Rate in Tonic-Atonic Seizure Frequency was presented as the number of participants who achieved a 50% reduction in tonic-atonic seizure frequency. | Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below. Participants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment. | Posted | Number | Participants | 12 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Total Seizure Frequency (Per 28 Days) | Percent change in the total seizure frequency (per 28 days) was calculated using the total seizure frequency per 28 days of the Observation Period as the baseline and the total seizure frequency per 28 days of the Treatment Period as the post-treatment value. Percentage change in total seizure frequency was calculated as follows: [100 x (post-treatment value - baseline)/ baseline]. | Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below. Participants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment. | Posted | Median | Full Range | Percent Change | Baseline (28 day observational period) and End of Treatment (28 day treatment period) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change in the Frequency of Seizures Other Than Tonic-atonic Seizures (Per 28 Days) | Percent change in the frequency of seizures other than tonic-atonic seizures (per 28 days) was calculated using the total seizure frequency per 28 days of the Observation Period as the baseline and the total seizure frequency per 28 days of the Treatment Period as the post-treatment value. Percentage change in total seizure frequency was calculated as follows: [100 x (post-treatment value - baseline)/ baseline]. Seizures analyzed other than tonic-atonic seizures included: Partial seizure freq. (frequency), Absence seizure, Atyp. (atypical) absence seizure, Myoclonic seizure, Clonic seizure, Tonic seizure, Tonic-clonic seizure, Atonic seizure, & Uncla. (unclassified) epileptic seizure. The frequency of epileptic seizures was recorded in the diary by the recorder. Seizure frequency was counted based on the classification established by the International League Against Epilepsy (ILAE). The diary recorder monitored the participant and recorded the seizure diary in a consistent manner. | Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below. Participants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment. | Posted | Median | Full Range | Percent change | Baseline (28 day observational period) and End of Treatment (28 day treatment period) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Global Impression of Change (CGIC) | CGIC in participants with Lennox-Gastaut Syndrome (LGS) relative to placebo was presented as number of participants in each category at the final assessment (last observation carried forward [LOCF]) & at Week 12 of the Treatment Period. The investigator assessed the CGIC by comparing the participants' condition during the 4 weeks immediately before the completion (or discontinuation [d/c]) of the Treatment Period to his/her condition during the 4-week Observation Period (for participants who d/c'd the study during the Treatment Period, the CGIC was assessed by comparing the participant's condition from the start to discontinuation of the study treatment to his/her condition during the 4-week Observation Period). The CGIC was assessed according to the following 7-grade scale based on the frequency & severity of seizures, AEs, and overall conditions of daily life. Markedly improved, Improved, Slightly improved, Unchanged, Slightly worsened, Worsened, Markedly worsened. | Full analysis set (FAS) is defined as participants who were registered for the Treatment Period and excludes those listed below. Participants who did not meet the inclusion criterion related the target disease, participants who did not take the study drug, participants without any evaluable efficacy data after the start of study treatment. | Posted | Number | participants | Up to Week 12 of the treatment period |
|
From date of first dose until date of last dose of study treatment, up to approximately 1 year 2 months
Treatment-emergent adverse events and treatment-emergent serious adverse events were reported for the safety analysis set, which consisted of participants who registered for the Treatment Period and excludes participants who did not take study drug and those without any evaluable safety data after the start of study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rufinamide (E2080) | Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening) | 1 | 29 | 27 | 29 | ||
| EG001 | Placebo | Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks. | 1 | 30 | 21 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug Eruption | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypothyroidism | Endocrine disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dental Caries | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Anal Fissure | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Aphthous Stomatitis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Gingival Bleeding | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Otitis Media | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Eye injury | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Tooth injury | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Blood Pressure Increased | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Blood Lactate Dehydrogenase Increased | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Blood Pressure Decreased | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Lymphocyte Count Decreased | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Status Epilepticus | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Autism | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Complex Partial Seizures | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Psychomotor Hyperactivity | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Tonic Convulsion | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Stereotypy | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dysmenorrhea | Reproductive system and breast disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Drug Eruption | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Skin Chapped | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Heat Rash | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Subcutaneous Haematoma | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Inc. | Eisai Call Center | 888-422-4743 |
| ID | Term |
|---|---|
| D065768 | Lennox Gastaut Syndrome |
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D000073376 | Epileptic Syndromes |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C079703 | rufinamide |
Not provided
Not provided
Not provided
| Male |
|
|
|
|
| OG001 |
| Placebo |
Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks. |
|
|
|
| OG001 | Placebo | Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks. |
|
|
|
| OG001 | Placebo | Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks. |
|
|
|