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NCT01465997 · ClinicalTrials.gov registry record · Phase 3
Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older
A Phase 3 study, sponsored by UCB Biosciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 551
- Enrollment target
NCT01465997: Completed Phase 3 study, sponsored by UCB Biosciences.
NCT01465997 is a Phase 3 study that has completed, run by UCB Biosciences. The registered enrollment target is 551 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01465997, a Phase 3 study, has completed, sponsored by UCB Biosciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 551 participants
- Enrollment target
Study Summary
Compare safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as monotherapy in newly or recently newly diagnosed subjects with primary safety variables including spontaneous reports of Adverse Events (AEs), withdrawal of subjects due to AEs, reporting of Serious AEs (SAEs).
Primary Outcome
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of SP0994 study medication, or events in which severity worsened on or after the date of first dose of SP0994 study medication. AEs which occurred within 30 days after last dose of study medication were considered treatment emergent.
Interventions
- DRUG Lacosamide
- DRUG Carbamazepine-Controlled Release (CBZ-CR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 551 participants |
| Start Date | 2012-05 |
| Est. Completion | 2017-01 |
| Phase | Phase 3 |
What the finished NCT01465997 record still lists
NCT01465997 is an interventional study that assigns participants to a tested intervention. The registered 551 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 (29% lower).
The record links to 0 conditions, and to 2 interventions - of which Lacosamide is the first listed.
NCT01465997 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01465997 about?
NCT01465997 is a clinical study titled "Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older". Compare safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as monotherapy in newly or recently newly diagnosed subjects with primary safety variables including spontaneous reports of Adverse Events (AEs), withdrawal of subjects due to AEs, reporting of Serious AEs (SAEs).
What is the current status of trial NCT01465997?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 551 participants. The study started on 2012-05. Estimated completion is 2017-01.
What interventions are being tested in trial NCT01465997?
The interventions under investigation include: Lacosamide (DRUG), Carbamazepine-Controlled Release (CBZ-CR) (DRUG).
Who is sponsoring clinical trial NCT01465997?
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 NCT01465997's enrollment target sits among peer trials
551 680th of 2000 higher than 1,321 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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