| Primary | Change in the Number of Seizure Days With Absence Seizures From the Baseline Phase to the Maintenance Phase | During the study subjects kept a diary to record daily seizure activity from Visit 1 until the end of study participation. The following information has been recorded:
- Seizure type
- Seizure frequency
A negative value in change of seizure days with absence seizures shows a decrease in seizure days with absence seizures. | Of the 49 subjects in the Safety Set (SS), 44 are included in this analysis. Data not available for 5 subjects. | Posted | | Mean | Standard Deviation | number of seizure days | | From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13) | | | | ID | Title | Description |
|---|
| OG000 | Lacosamide | Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week. |
| | | Title | Denominators | Categories |
|---|
| | |
| |
| Primary | Change in the Number of Seizure Days With Myoclonic Seizures From the Baseline Phase to the Maintenance Phase | During the study subjects kept a diary to record daily seizure activity from Visit 1 until the end of study participation. The following information has been recorded:
- Seizure type
- Seizure frequency
A negative value in change of seizure days with myoclonic seizures shows a decrease in seizure days with myoclonic seizures. | Of the 49 subjects in the Safety Set (SS), 44 are included in this analysis. Data not available for 5 subjects. | Posted | | Mean | Standard Deviation | number of seizure days | | From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13) | | | | ID | Title | Description |
|---|
| OG000 | Lacosamide | Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week. |
| |
| Secondary | Changes in Count of Generalized Spike-wave Discharges on 24-hour Ambulatory Electroencephalogram (EEG) From Visit 2 (Baseline Phase) to Visit 6 (Maintenance Phase) | Subjects were asked to return to the clinic on the morning of the day prior to Visit 2 and Visit 6 to begin 24-hour ambulatory EEG recordings for evaluation of spike-wave discharges. Only subjects with an evaluable EEG measurement with > 19 interpretable hours at Visit 2 and Visit 6 are included in this analysis. The general spike-wave discharges are calculated per interpretable hours. | Of the 49 subjects in the Safety Set (SS), 40 subjects are included in this analysis. Data not available for 9 subjects. | Posted | | Mean | Standard Deviation | 1/hour | | From Visit 2 (Week 4) to Visit 6 (Week 8) | | | | ID | Title | Description |
|---|
| OG000 | Lacosamide | Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week. |
| |
| Secondary | Changes in Count of 3 Hertz (Hz) Spike-wave Discharges (During Waking Hours) on 24-hour Ambulatory Electroencephalogram (EEG) From Visit 2 (Baseline Phase) to Visit 6 (Maintenance Phase) | Subjects were asked to return to the clinic on the morning of the day prior to Visit 2 and Visit 6 to begin 24-hour ambulatory EEG recordings for evaluation of spike-wave discharges. Only subjects with an evaluable EEG measurement with > 19 interpretable hours at Visit 2 and Visit 6 are included in this analysis. The 3 Hertz (Hz) spike-wave discharges are calculated per awake hours. | Of the 49 subjects in the Safety Set (SS), 40 subjects are included in this analysis. Data not available for 9 subjects. | Posted | | Mean | Standard Deviation | 1/hour | | From Visit 2 (Week 4) to Visit 6 (Week 8) | | | | ID | Title | Description |
|---|
| OG000 | Lacosamide | Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week. |
| |
| Secondary | Number of Subjects With Treatment Emergent Adverse Events (TEAEs) During the 10-week Treatment Period | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. | All 49 subjects in the Safety Set (SS) are included in this analysis. | Posted | | Number | | participants | | From Visit 2 (Week 4) to Visit 7 (Week 13) | | | | ID | Title | Description |
|---|
| OG000 | Lacosamide | Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week. |
| |
| Secondary | Number of Subjects Withdrawn From the Study Due to Treatment Emergent Adverse Events (TEAEs) During the 10-week Treatment Period | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. | All 49 subjects in the Safety Set (SS) are included in this analysis. | Posted | | Number | | participants | | From Visit 2 (Week 4) to Visit 7 (Week 13) | | | | ID | Title | Description |
|---|
| OG000 | Lacosamide | Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week. |
| |