Epilepsy and epilepsy syndrome
Conditions
Interventions
investigational material(s)
Generic name etc : SPM927
INN of investigational material : Lacosamide
Therapeutic category code : 113 Antiepileptics
Dosage and Administration for Investigational material
Sponsors
UCB Japan Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject must have completed or be an eligible Baseline failure from the parent study (SP0982). Note: Other subjects screened for SP0982 may be considered for roll-over to EP0012 if the investigator considers that the subject could benefit from treatment with open-label lacosamide (LCM) and based on prior discussion with and approval from the UCB Study Physician or representative.
Exclusion criteria
Exclusion criteria: - Subject is receiving any investigational drugs or using any experimental devices in addition to Lacosamide (LCM) - Subject meets the withdrawal criteria for SP0982 or is experiencing an ongoing serious adverse event (SAE) - Subject has an active suicidal ideation as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Since Last Visit" version of the Columbia-Suicide Severity Rating Scale (C-SSRS) - Subject has >=2x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (>=1.5xULN total bilirubin if known Gilbert's syndrome). If subject has elevations only in total bilirubin that are >ULN and ULN for ALT, AST, ALP, or total bilirubin, a Baseline diagnosis and/or the cause of any clinically meaningful elevation must be understood and recorded in the Case Report form (CRF). If subject has >ULN ALT, AST, or ALP that does not meet the exclusion limit at screening, repeat the tests, if possible, prior to dosing to ensure there is no further ongoing clinically relevant increase. In case of a clinically relevant increase, inclusion of the subject must be discussed with the Medical Monitor. Tests that result in ALT, AST, or ALP up to 25% above the exclusion limit may be repeated once for confirmation. This includes re-screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy 1.Number of subjects experiencing at least one Adverse Event (AE) during the study 2.Number of subjects withdrawing due to Adverse Events (AEs) during the study 3.Incidence of new seizure types during the Treatment Period 4.Number of subjects with an increase of up to 25% in days with absence seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982) 5.5.Number of subjects with an increase of >25% to 50% in days with absence seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982) 6.Number of subjects with an increase of >50% to 75% in days with absence seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982) 7.Number of subjects with an increase of >75% in days with absence seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982) 8.Number of subjects with an increase of up to 25% in days with myoclonic seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982) 9.Number of subjects with an increase of >25% to 50% in days with myoclonic seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982) 10.Number of subjects with an increase of >50% to 75% in days with myoclonic seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982) 11.Number of subjects with an increase of >75% in days with myoclonic seizures per 28 days during the Treatment Period as compared to the Prospective Baseline (of study SP0982) | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy 1.Percent change in Primary Generalized Tonic-clonic (PGTC) seizure frequency per 28 days from Combined Baseline [ Time Frame: From Combined Baseline until Termination Visit (up to 5 years) ] Percent change in PGTC seizure frequency per 28 days from Combined Baseline, where Combined Baseline is defined as the combined 12-week Historical Baseline and 4-week Prospective Baseline periods immediately prior to randomization in the parent study (SP0982). 2.Percentage of treatment-emergent marked abnormalities in hematology parameters [ Time Frame: During the study (up to 5 years) ] 3.Percentage of treatment-emergent marked abnormalities in chemistry parameters [ Time Frame: During the study (up to 5 years) ] 4.Percentage of treatment-emergent marked abnormalities in 12-lead electrocardiogram (ECGs) [ Time Frame: During the study (up to 5 years) ] 5.Percentage of treatment-emergent marked abnormalities in vital sign measurements [ Time Frame: During the study (up to 5 years) ] | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania
Outcome results
None listed