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NCT01142193 · ClinicalTrials.gov registry record · Phase 3

Study to Evaluate the Safety and Effectiveness of USL255 in Patients With Refractory Partial-onset Seizures

A Phase 3 study of Epilepsy, sponsored by Upsher-Smith Laboratories.

Completed
Registry status
Phase 3
Development phase
249
Enrollment target
20
Study locations

NCT01142193 is a Phase 3 study of Epilepsy that has completed, run by Upsher-Smith Laboratories. The registered enrollment target is 249 participants, below the 951-participant average among 160 other Epilepsy trials with a reported enrollment target (74% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT01142193, a Phase 3 study of Epilepsy, has completed, sponsored by Upsher-Smith Laboratories.

COMPLETED
Registry status
Phase 3
Development phase
249 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to examine the safety and effectiveness of USL255 as adjunctive therapy in patients with refractory partial onset-seizures.

Conditions Studied

Epilepsy

Interventions

  • DRUG Placebo
  • DRUG USL255

Study Locations (20)

Florida

  • - Gainesville
  • - Gulf Breeze
  • - Jacksonville
  • - Pensacola
  • - Port Charlotte

Missouri

  • - Chesterfield
  • - St Louis

Texas

  • - Dallas
  • - Temple

Arizona

  • - Phoenix

California

  • - Ventura

Idaho

  • - Boise

Kentucky

  • - Lexington

Maryland

  • - Waldorf

Trial Details

FieldValue
Enrollment Target 249 participants
Start Date 2010-05
Est. Completion 2013-01
Phase Phase 3

Sponsor

Upsher-Smith Laboratories

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01142193

The ClinicalTrials.gov registry entry for NCT01142193 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 249 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 951-participant average among 160 other Epilepsy trials with a reported enrollment target (74% lower). The listed sponsor is Upsher-Smith Laboratories, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Epilepsy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01142193 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Florida, Missouri, Texas.

Frequently Asked Questions

What is clinical trial NCT01142193 about?

NCT01142193 is a clinical study titled "Study to Evaluate the Safety and Effectiveness of USL255 in Patients With Refractory Partial-onset Seizures". The purpose of this study is to examine the safety and effectiveness of USL255 as adjunctive therapy in patients with refractory partial onset-seizures.

What is the current status of trial NCT01142193?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 249 participants. The study started on 2010-05. Estimated completion is 2013-01.

What conditions does trial NCT01142193 study?

This clinical trial studies the following conditions: Epilepsy.

What interventions are being tested in trial NCT01142193?

The interventions under investigation include: Placebo (DRUG), USL255 (DRUG).

Who is sponsoring clinical trial NCT01142193?

This trial is sponsored by Upsher-Smith Laboratories, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01142193 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Idaho, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.