partial seizures with or without secondary generalization MedDRA version: 6.0 Level: LLT Classification code 10034089
Conditions
Interventions
Product Name: SPM 927
Product Code: ADD 234037
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Lacosamide
CAS Number: 175481-37-5
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
SCHWARZ BIOSCIENCES Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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? 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Czech Republic, Germany, Lithuania, Sweden
Outcome results
None listed