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NCT00961441 · ClinicalTrials.gov registry record · Phase 2
Study Evaluating the Pharmacokinetics of Keppra Extended Release (XR) in Children and Adults With Epilepsy
A Phase 2 study, sponsored by UCB Biosciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT00961441: Completed Phase 2 study, sponsored by UCB Biosciences.
NCT00961441 is a Phase 2 study that has completed, run by UCB Biosciences. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00961441, a Phase 2 study, has completed, sponsored by UCB Biosciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
To study how the body absorbs, distributes, metabolises and eliminates Keppra XR in both children (12 to 16 years old) and adults (18 to 55 years old) with epilepsy.
Primary Outcome
The Cmax is the maximum plasma concentration normalized by dose and by body weight and dose. Cmax normalized by 1000 mg dose was calculated as: Cmax/(mg dose taken/ 1000 mg Keppra XR). Cmax normalized by body weight and dose (1 mg Keppra XR/kg) was calculated as: Cmax/(bodyweight (kg)/ mg dose Keppra XR taken). Pharmacokonetic (PK) samples were taken predose and 1h, 2.5h, 4h, 6h and 10h after study medication at day 4, 5, 6 or 7 of Keppra XR administration.
Interventions
- DRUG Keppra XR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2009-09 |
| Est. Completion | 2010-03 |
| Phase | Phase 2 |
What the finished NCT00961441 record still lists
NCT00961441 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 1 intervention - of which Keppra XR is the first listed.
NCT00961441 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00961441 about?
NCT00961441 is a clinical study titled "Study Evaluating the Pharmacokinetics of Keppra Extended Release (XR) in Children and Adults With Epilepsy". To study how the body absorbs, distributes, metabolises and eliminates Keppra XR in both children (12 to 16 years old) and adults (18 to 55 years old) with epilepsy.
What is the current status of trial NCT00961441?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2009-09. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00961441?
The interventions under investigation include: Keppra XR (DRUG).
Who is sponsoring clinical trial NCT00961441?
This trial is sponsored by UCB Biosciences, which has 39 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00961441's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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