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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 is a Phase 3 study that has completed, run by UCB Biosciences. The registered enrollment target is 888 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01243177
The ClinicalTrials.gov registry entry for NCT01243177 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 888 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UCB Biosciences, which has 39 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Lacosamide is the first listed.
NCT01243177 reports 0 study locations.
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.
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