A multi-center, open-label trial to investigate the safety and tolerability of intravenous SPM 927 as replacement for oral SPM 927 in subjects with partial seizures with or without secondary generalization.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 160

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, in the opinion of the investigator, adequate seizure control for participation in the trial, and is willing and able to comply with all trial requirements including hospitalization, multiple blood draws and intravenous infusions.
3. Subject is currently enrolled in an open-label extension trial receiving oral SPM 927 for the treatment of partial seizures and has been enrolled for at least 8 weeks.
4. Subject has been on a stable bid dosage regimen between 200mg/day and 600mg/day SPM 927, inclusive, for the last 2 weeks.
5. Subject has been on a stable bid dosage regimen of 700 or 800mg/day SPM 927 for the last 2 weeks. Applicable only if doses above 600mg/day are allowed (see Section 11.1.5.2).
6. Subject has been on a stable dose of concomitant AED(s) for the last 2 weeks.
7. Subject has had stable VNS settings for the last 2 weeks, if applicable
SPM 927.
Are the trial subjects under 18? no
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

1. Subject is receiving any investigational drugs or using any experimental devices other than SPM 927.
2. Subject has previously received iv SPM 927.
3. Subject meets the withdrawal criteria for the open-label extension trial.
4. Subject has any medical or psychiatric condition that, in the opinion of the investigator, would compromise the subject’s ability to participate in this trial or possibly confound interpretation of the data.
5. Subject has diastolic blood pressure less than 50mm Hg or greater than 105mm Hg or heart rate less than 50 beats per minute (bpm) or greater than 110bpm, measured in a supine position after 3 minutes at rest.
6. Subject has a history of any kind of status epilepticus within the 12-month period prior to trial entry.
7. Subject has confirmed clinically relevant abnormality by ECG.

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 to evaluate the safety and tolerability of SPM 927 when given as iv infusions in subjects who are receiving oral SPM 927 in addition to up to 3 concomitant AEDs for partial seizures with or without secondary generalization.;Secondary Objective: ./.;Primary end point(s): The primary variables are AEs as well as the results of vital signs monitoring, ECGs, clinical laboratory tests, physical examination, and neurological examination.

Secondary Outcome Measures

Name	Time	Method

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