Epilepsy
Conditions
Keywords
Epilepsy
Brief summary
The purpose of this trial was to evaluate the safety and tolerability of SPM 927 when given as iv infusions compared with oral administration of the same dose strengths in subjects who were receiving oral SPM 927 for partial seizures with or without secondary generalization. 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
DRUGiv SPM 927 and oral placebo tablet
60-minute infusion iv SPM 927 and oral placebo tablet
DRUGoral SPM 927 tablet and iv placebo
60-minute infusion placebo and oral SPM 927 tablet
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subject with partial seizures with or without secondary generalization
Exclusion criteria
* Subject had previously received iv SPM 927 * Subject met the withdrawal criteria for the open-label extension trial with SPM 927 or was experiencing an ongoing serious adverse event.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events, Vital signs, electrocardiograms,Physical examination, neurological examination | 2 Days |
Secondary
| Measure | Time frame |
|---|---|
| Seizure counts | 2 days |
Outcome results
None listed