An international open-label extension trial to determine safety and efficacy of long-term oral SPM 927 in patients with partial seizures

Conditions: Partial seizures
MedDRA version: 6.0Level: LLTClassification code 10034089

Registration Number: EUCTR2004-000152-16-LT

Lead Sponsor: SCHWARZ BIOSCIENCES GmbH; A member of the UCB group

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 577

Inclusion Criteria

Subjects must fulfill the following inclusion criteria:

1. Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent.

2. Subject has completed the Maintenance and Transition Phases of the clinical trial, SP755, for the treatment of partial seizures.

3. Subject is expected to benefit from participation, in the opinion of the investigator.

4. Subject is willing and able to comply with all trial requirements.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects are not permitted to enroll in the trial if any of the following criteria are met:

1. Subject is receiving any investigational drugs or using any experimental devices in addition to SPM 927.

2. Subject meets the withdrawal criteria for the previous trial (SP755) or is experiencing an 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: The objectives of this trial are: <br><br>• To obtain information about the safety of SPM 927 during long-term exposure <br><br>• To obtain data on seizure reduction and the maintenance of efficacy by SPM 927 during long-term exposure<br><br>• To allow subjects who have completed an SPM 927 epilepsy trial to receive SPM 927<br>;Secondary Objective: ./.;Primary end point(s): Safety and tolerability will be assessed using the following variables:<br><br>• Adverse events reported spontaneously by the subject and/or caregiver or observed by the investigator<br><br>• Subject withdrawal due to adverse events<br><br>• Changes in hematology, blood chemistry, and urinalysis parameters<br><br>• Changes in 12-lead ECGs<br><br>• Changes in vital sign measurements (i.e., blood pressure, heart rate)<br><br>• Changes in physical or neurological examination findings<br><br>• Changes in body weight<br>

Secondary Outcome Measures