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NCT00419094 · ClinicalTrials.gov registry record · Phase 3
Conversion to Monotherapy Study With Keppra XR for Partial Seizures
A Phase 3 study, sponsored by UCB Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 228
- Enrollment target
NCT00419094: Completed Phase 3 study, sponsored by UCB Pharma.
NCT00419094 is a Phase 3 study that has completed, run by UCB Pharma. The registered enrollment target is 228 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00419094, a Phase 3 study, has completed, sponsored by UCB Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 228 participants
- Enrollment target
Study Summary
The primary objective of this study is to assess the efficacy of two doses of Keppra XR compared with a historical control as the placebo, in the monotherapy treatment of partial onset seizures.
Primary Outcome
Cumulative exit rate at day 112, based on the duration between start date of previous AED tapering to the earliest date exit criterion was met; calculated using Kaplan Meier Methods. Subjects prematurely discontinued for reasons unrelated to exit criteria were censored as of last dose of study drug. Subjects who completed without meeting exit criteria were censored at Day 112. Exit criteria include increase in seizure frequency, severity, duration, status epilepticus, or new generalized seizure.
Interventions
- DRUG Keppra XR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 228 participants |
| Start Date | 2007-08 |
| Est. Completion | 2009-09 |
| Phase | Phase 3 |
What the finished NCT00419094 record still lists
NCT00419094 is an interventional study that assigns participants to a tested intervention. The registered 228 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which Keppra XR is the first listed.
NCT00419094 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00419094 about?
NCT00419094 is a clinical study titled "Conversion to Monotherapy Study With Keppra XR for Partial Seizures". The primary objective of this study is to assess the efficacy of two doses of Keppra XR compared with a historical control as the placebo, in the monotherapy treatment of partial onset seizures.
What is the current status of trial NCT00419094?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 228 participants. The study started on 2007-08. Estimated completion is 2009-09.
What interventions are being tested in trial NCT00419094?
The interventions under investigation include: Keppra XR (DRUG).
Who is sponsoring clinical trial NCT00419094?
This trial is sponsored by UCB Pharma, which has 100 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00419094's enrollment target sits among peer trials
228 1309th of 2000 higher than 691 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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