The purpose is to assess the safety of Lacosamide in subjects with uncontrolled Primary Generalized Tonic-Clonic (PGTC) seizures with Idiopathic Generalized Epilepsy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
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.
Unnamed facility
Alabaster, Alabama, United States
Unnamed facility
Phoenix, Arizona, United States
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.
Time frame: From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13)
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.
Time frame: From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13)
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.
Time frame: From Visit 2 (Week 4) to Visit 6 (Week 8)
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.
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Unnamed facility
Little Rock, Arkansas, United States
Unnamed facility
San Francisco, California, United States
Unnamed facility
Aurora, Colorado, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Rome, Georgia, United States
Unnamed facility
Boise, Idaho, United States
Unnamed facility
Fort Wayne, Indiana, United States
Unnamed facility
Lexington, Kentucky, United States
...and 15 more locations
Time frame: From Visit 2 (Week 4) to Visit 6 (Week 8)
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.
Time frame: From Visit 2 (Week 4) to Visit 7 (Week 13)
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.
Time frame: From Visit 2 (Week 4) to Visit 7 (Week 13)