A Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous SPM 927
Phase 2
Completed
- Conditions
- Epilepsy
- Interventions
- Drug: iv SPM 927 and oral placebo tabletDrug: oral SPM 927 tablet and iv placebo
- Registration Number
- NCT00800215
- Lead Sponsor
- UCB Pharma
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 iv SPM 927 and oral placebo tablet - 2 oral SPM 927 tablet and iv placebo - 3 iv SPM 927 and oral placebo tablet - 4 oral SPM 927 tablet and iv placebo -
- Primary Outcome Measures
Name Time Method Adverse events, Vital signs, electrocardiograms,Physical examination, neurological examination 2 Days
- Secondary Outcome Measures
Name Time Method Seizure counts 2 days