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-BE
• Lead Sponsor: CB BIOSCIENCES, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-05
• Last Update Posted: 26 September 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent/Assent Form for the open-label extension study (EP0012) must be signed and dated by the subject or by the parent(s) or legal representative. The Informed Consent Form or a specific Assent Form, where required, will be signed and dated by minors.

2. Subject must have completed or be an eligible Baseline failure from the parent study (SP0982), as defined in protocol Section 5.1.
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 LCM and based on prior discussion with and approval from UCB Study Physician or representative

3. Subject/legally acceptable representative considered as reliable and capable of adhering to the protocol (eg, able to understand and complete diaries and questionnaires), visit schedule and medication intake according to the judgment of the investigator.
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified