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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 is a Phase 3 study that has completed, run by UCB Biosciences. The registered enrollment target is 551 participants.

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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).

Interventions

  • DRUG Lacosamide
  • DRUG Carbamazepine-Controlled Release (CBZ-CR)

Trial Details

FieldValue
Enrollment Target 551 participants
Start Date 2012-05
Est. Completion 2017-01
Phase Phase 3

Sponsor

UCB Biosciences

39 total trials

What the Registry Record Tells You About NCT01465997

The ClinicalTrials.gov registry entry for NCT01465997 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 551 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.

NCT01465997 reports 0 study locations.

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.

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.