SAFETY AND EFFICACY OF LACOSMIDE AS ADDITIONAL THERAPY IN PATIENTS SUFFERING FROM EPILEPTIC TONIC-CLONIC SEIZURES

Phase 1

Active, not recruiting

• Conditions: Idiopathic generalized epilepsy; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-001770-29-PT
• Lead Sponsor: CB BIOSCIENCES, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-21
• Study Completion: 2023-03-30
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 239

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 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

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 <1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin <35%).
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