A Multicenter, Double-blind, Double-dummy, Randomized Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous SPM 927 as Replacement for Oral SPM 927 in Subjects With Partial Seizures With or Without Secondary Generalization
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- UCB Pharma
- Enrollment
- 60
- Primary Endpoint
- Adverse events, Vital signs, electrocardiograms,Physical examination, neurological examination
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
1
Intervention: iv SPM 927 and oral placebo tablet (Drug)
2
Intervention: oral SPM 927 tablet and iv placebo (Drug)
3
Intervention: iv SPM 927 and oral placebo tablet (Drug)
4
Intervention: oral SPM 927 tablet and iv placebo (Drug)
Outcomes
Primary Outcomes
Adverse events, Vital signs, electrocardiograms,Physical examination, neurological examination
Time Frame: 2 Days
Secondary Outcomes
- Seizure counts(2 days)