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NCT00151879 · ClinicalTrials.gov registry record · Phase 2
Safety and Tolerability of Intravenous SPM 927 as Replacement for Oral SPM 927 in Subjects With Partial Seizures
A Phase 2 study, sponsored by UCB Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 160
- Enrollment target
NCT00151879 is a Phase 2 study that has completed, run by UCB Pharma. The registered enrollment target is 160 participants.
The verdict
NCT00151879, a Phase 2 study, has completed, sponsored by UCB Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 160 participants
- Enrollment target
Study 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
- DRUG SPM 927
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2005-02 |
| Est. Completion | 2006-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00151879
The ClinicalTrials.gov registry entry for NCT00151879 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UCB Pharma, which has 100 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which SPM 927 is the first listed.
NCT00151879 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00151879 about?
NCT00151879 is a clinical study titled "Safety and Tolerability of Intravenous SPM 927 as Replacement for Oral SPM 927 in Subjects With Partial Seizures". 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 S...
What is the current status of trial NCT00151879?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2005-02. Estimated completion is 2006-05.
What interventions are being tested in trial NCT00151879?
The interventions under investigation include: SPM 927 (DRUG).
Who is sponsoring clinical trial NCT00151879?
This trial is sponsored by UCB Pharma, which has 100 total clinical trials registered on ClinicalTrials.gov.
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