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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.

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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

FieldValue
Enrollment Target 888 participants
Start Date 2011-04
Est. Completion 2015-08
Phase Phase 3

Sponsor

UCB Biosciences

39 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.