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NCT01091662 · ClinicalTrials.gov registry record · Phase 3
Safety & Efficacy of Eslicarbazepine Monotherapy in Sub.w/Partial Epilepsy Not Well Controlled by Current Antiepileptic
A Phase 3 study, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 3
- Development phase
- 172
- Enrollment target
NCT01091662: Completed Phase 3 study, sponsored by Sumitomo Pharma America.
NCT01091662 is a Phase 3 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 172 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01091662, a Phase 3 study, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 172 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 following five exit criteria over a 16-week study period (from start of AED taper/con. period (Wk 3) to end of double blind monotherapy period (Wk 18)).1.One episode of status epilepticus.2.One secondary gen. partial seizure (in subjects who did not have gen.seizures during 6 mo. prior to screening).3.A two fold increase in any consecutive 28 day seizure rate compared to the highest consecutive 28 day seiz
Interventions
- DRUG Eslicarbazepine acetate 1600 mg
- DRUG Eslicarbazepine acetate 1200 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 172 participants |
| Start Date | 2010-06 |
| Est. Completion | 2012-11 |
| Phase | Phase 3 |
What the finished NCT01091662 record still lists
NCT01091662 is an interventional study that assigns participants to a tested intervention. The registered 172 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 (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Eslicarbazepine acetate 1600 mg is the first listed.
NCT01091662 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01091662 about?
NCT01091662 is a clinical study titled "Safety & Efficacy of Eslicarbazepine Monotherapy in Sub.w/Partial Epilepsy Not Well Controlled by Current Antiepileptic". 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 NCT01091662?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 172 participants. The study started on 2010-06. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01091662?
The interventions under investigation include: Eslicarbazepine acetate 1600 mg (DRUG), Eslicarbazepine acetate 1200 mg (DRUG).
Who is sponsoring clinical trial NCT01091662?
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 NCT01091662's enrollment target sits among peer trials
172 1448th of 2000 higher than 550 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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