Epilepsies, Partial
Conditions
Keywords
partial seizures with or without secondary generalization
Brief summary
Subjects enrolled in the SP615, SP756, or SP774 open-label extension (OLE) trials receiving oral SPM 927 for at least 8 weeks and a stable dose of up to 3 antiepileptic medications may participate in a research trial at approximately 30 locations. Trial objectives include investigating whether iv SPM 927 is safe and well tolerated when given twice daily for a short period of time and identifying the appropriate infusion rate(s). Subjects will receive SPM 927 as a 30-, 15- or 10- minute infusions twice daily for 2 - 5 days based on notification by the research doctor and subject choice. Subjects will remain on the same stable dose as received in the OLE trial. Trial procedures will include medical history update, physical/ neurological exams, ECGs, blood /urine sample collections and seizure diary completion. Subjects completing the trial will return to the OLE trial to resume dosing with oral SPM 927.
Interventions
DRUGSPM 927
Sponsors
UCB Pharma
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Partial seizures with or without secondary generalization.
Exclusion criteria
* Subject has previously received iv lacosamide. * Subject meets the withdrawal criteria for the open-label extension trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the safety and tolerability of lacosamide when given as iv infusions in subjects who are receiving oral lacosamide in addition to up to 3 concomitant AEDs for partial seizures. The primary variables are adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Seizure counts, trough and measured maximum concentration for lacosamide as well as the O-desmethyl-metabolite. | — |
Countries
United States
Outcome results
None listed