Idiopathic generalized epilepsy
Conditions
Interventions
Trade Name: Vimpat 50 mg film-coated tablets
Product Name: Lacosamide
Product Code: SPM927
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: LACOSAMIDE
Current Sponsor code: SPM 927
Concent
Sponsors
UCB BIOSCIENCES, Inc.
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 and based on prior discussion with and approval from the UCB Study Physician or representative Are the trial subjects under 18? yes Number of subjects for this age range: 60 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 170 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Subject is receiving any investigational drugs or using any experimental devices in addition to 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). The subject should be referred immediately to a Mental Healthcare Professional. 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 electronic Case Report form (eCRF). Tests that result in ALT, AST, or ALP up to 25% above the exclusion limit may be repeated once for confirmation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the safety and tolerability of LCM as an adjunctive therapy for uncontrolled PGTC seizures in subjects with IGE during long-term exposure.;Secondary Objective: To assess the efficacy of adjunctive LCM therapy during long-term exposure for the treatment of subjects with IGE experiencing uncontrolled PGTC seizures To allow subjects who have completed SP0982 and eligible Baseline failures from SP0982 to receive LCM;Primary end point(s): 1. Number of subjects with treatment-emergent adverse events (TEAEs) over the duration of the Treatment Period 2. Number of subjects withdrawn due to TEAEs 3. Number of subjects with new appearance of absence and/or myoclonic seizures during the Treatment Period 4. Number of subjects with an increase of up to 25% in days with absence seizures per 28 days compared to the Prospective Baseline (of study SP0982) 5. Number of subjects with an increase of >25% to 50% in days with absence seizures per 28 days 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 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 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 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 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 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 compared to the Prospective Baseline (of study SP0982) 12. Percentage of subjects with at least 50% wo | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Percentage of treatment-emergent marked abnormalities in hematology parameters 2. Percentage of treatment-emergent marked abnormalities in chemistry parameters 3. Percentage of treatment-emergent marked abnormalities in 12-lead electrocardiogram (ECGs) 4. Percentage of treatment-emergent marked abnormalities in vital sign measurements 5. Percent change in Primary Generalized Tonic-clonic seizure (PGTCS) frequency per 28 days from Combined Baseline;Timepoint(s) of evaluation of this end point: 1. - 4. During the study (up to 5 years) 5. From Combined Baseline until Termination Visit (up to 5 years) | — |
Countries
Australia, Belgium, Brazil, Bulgaria, China, Czechia, Czech Republic, France, Germany, Hungary, Israel, Italy, Japan, Korea, Republic of, Mexico, Poland, Portugal, Romania, Russian Federation, Slovakia, Spain, Taiwan, Turkey, United States
Contacts
Public ContactClin Trial Reg & Results disclosure
UCB BIOSCIENCES GmbH
Outcome results
None listed