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NCT00866775 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Eslicarbazepine Acetate Monotherapy in Subjects With Partial Epilepsy Not Well Controlled by Current Antiepileptic Drugs
A Phase 3 study, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 3
- Development phase
- 193
- Enrollment target
NCT00866775: Completed Phase 3 study, sponsored by Sumitomo Pharma America.
NCT00866775 is a Phase 3 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 193 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00866775, a Phase 3 study, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 193 participants
- Enrollment target
Study Summary
This is an 18-week, double-blind, multicenter study with gradual conversion from previous antiepileptic therapy to eslicarbazepine acetate monotherapy in subjects with partial epilepsy.
Primary Outcome
Cumulative exit rate was defined as the proportion of subjects meeting at least one of the five exit criteria over a 16-wk study period (start of Antiepilectic Drugs(AED) taper/conv.period (Wk 3 to end of double blind monotherapy period (Wk 18)):1.One episode of status epilepticus.2.One secondary general partial seizure (in subjects who did not have gen. seizures during 6 months prior to screening).3.A two fold increase in any consecutive 28 day seizure rate compared to the highest consecutive 2
Interventions
- DRUG Eslicarbazepine acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 193 participants |
| Start Date | 2009-04 |
| Est. Completion | 2013-05 |
| Phase | Phase 3 |
What the finished NCT00866775 record still lists
NCT00866775 is an interventional study that assigns participants to a tested intervention. The registered 193 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 (75% lower).
The record links to 0 conditions, and to 1 intervention - of which Eslicarbazepine acetate is the first listed.
NCT00866775 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00866775 about?
NCT00866775 is a clinical study titled "Safety and Efficacy of Eslicarbazepine Acetate Monotherapy in Subjects With Partial Epilepsy Not Well Controlled by Current Antiepileptic Drugs". This is an 18-week, double-blind, multicenter study with gradual conversion from previous antiepileptic therapy to eslicarbazepine acetate monotherapy in subjects with partial epilepsy.
What is the current status of trial NCT00866775?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 193 participants. The study started on 2009-04. Estimated completion is 2013-05.
What interventions are being tested in trial NCT00866775?
The interventions under investigation include: Eslicarbazepine acetate (DRUG).
Who is sponsoring clinical trial NCT00866775?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00866775's enrollment target sits among peer trials
193 1397th of 2000 higher than 603 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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