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NCT01243177 · ClinicalTrials.gov registry record · Phase 3
Trial Comparing the Efficacy and Safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR); Initial Monotherapy in Epilepsy; Subjects Aged 16 and Older
A Phase 3 study, sponsored by UCB Biosciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 888
- Enrollment target
NCT01243177: Completed Phase 3 study, sponsored by UCB Biosciences.
NCT01243177 is a Phase 3 study that has completed, run by UCB Biosciences. The registered enrollment target is 888 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01243177, a Phase 3 study, has completed, sponsored by UCB Biosciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 888 participants
- Enrollment target
Study Summary
Compare efficacy and safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as monotherapy in newly or recently newly diagnosed subjects with a primary efficacy endpoint of 6-month seizure freedom. Noninferiority design to show a similar risk/benefit balance between Lacosamide (LCM) and Carbamazepine-CR (CBZ-CR).
Primary Outcome
The proportion of subjects remaining seizure free for 6 months (26 weeks) was estimated using Kaplan-Meier methods.
Interventions
- DRUG Lacosamide
- DRUG Carbamazepine-Controlled Release
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 888 participants |
| Start Date | 2011-04 |
| Est. Completion | 2015-08 |
| Phase | Phase 3 |
What the finished NCT01243177 record still lists
NCT01243177 is an interventional study that assigns participants to a tested intervention. The registered 888 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% higher).
The record links to 0 conditions, and to 2 interventions - of which Lacosamide is the first listed.
NCT01243177 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01243177 about?
NCT01243177 is a clinical study titled "Trial Comparing the Efficacy and Safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR); Initial Monotherapy in Epilepsy; Subjects Aged 16 and Older". Compare efficacy and safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as monotherapy in newly or recently newly diagnosed subjects with a primary efficacy endpoint of 6-month seizure freedom. Noninferiority design to show a similar risk/benefit balance between Lacosamide (LCM)...
What is the current status of trial NCT01243177?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 888 participants. The study started on 2011-04. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01243177?
The interventions under investigation include: Lacosamide (DRUG), Carbamazepine-Controlled Release (DRUG).
Who is sponsoring clinical trial NCT01243177?
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 NCT01243177's enrollment target sits among peer trials
888 364th of 2000 higher than 1,637 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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