SAFETY AND EFFICACY OF LACOSMIDE AS ADDITIONAL THERAPY IN PATIENTS SUFFERING FROM EPILEPTIC TONIC-CLONIC SEIZURES
- Conditions
- Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Idiopathic generalized epilepsy
- Registration Number
- EUCTR2012-001770-29-BG
- Lead Sponsor
- CB BIOSCIENCES, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 250
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 rollover 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
1. Subject is receiving any investigational drugs or using any experimental devices in addition to LCM.
2. Subject meets the withdrawal criteria for SP0982 or is experiencing an ongoing serious adverse event (SAE).
3. 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.
4. 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 <1.5xULN, fractionate bilirubin to
identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin
<35%).
5. For all subjects who entered EP0012 directly with a Baseline result >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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method