Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures

Conditions: Partial Epilepsies
MedDRA version: 17.1Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2014-004398-18-Outside-EU/EEA

Lead Sponsor: CB BIOSCIENCES, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 300

Inclusion Criteria

Completion of parent clinical trial for treatment of partial seizures
Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 280
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Receiving any study drug or experimental device other than lacosamide
- Meets withdrawal criteria for parent trial or experiencing ongoing serious adverse event

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - To obtain information about the safety of SPM 927 during long-term exposure<br>- To obtain data on seizure reduction and the maintenance of efficacy by SPM 927 during long-term exposure<br>- To allow subjects who have completed an SPM 927 epilepsy trial to receive SPM 927;Secondary Objective: Not applicable;Primary end point(s): - Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years) <br>- Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years) <br>- Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 6 Years) ;Timepoint(s) of evaluation of this end point: During the Treatment Period (Maximum 6 years)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years)<br>- Percentage of at Least 50 % Responders During the Treatment Period (Maximum 6 Years) <br>;Timepoint(s) of evaluation of this end point: - Baseline (8-week Baseline Period from the parent study SP0754)<br>- Treatment Period (Maximum 6 years)