Open-label Extension Study to Evaluate the Safety of USL255 in Patients With Refractory Partial-onset Seizures

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

Completed

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Buenos Aires, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Have completed the maintenance period of the P09-004 study.
Continue to be treated with a stable dose of 1 to a maximum of 3 approved concomitant AEDs.

Treatment and study plan

USL255

Drug

Other names: Topiramate extended-release

Primary outcomes

Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations

Time frame: Open label treatment of up to 62 weeks

Sponsors and collaborators

Lead sponsor

Upsher-Smith Laboratories

Industry

Registry information

Official study title

Open-Label Extension Study to Evaluate the Safety of USL255 as Adjunctive Therapy in Patients With Refractory Partial-Onset Seizures Who Had Participated in P09-004, a Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study

Important dates

Study start: 2010
Primary completion: 2014
Study completion: 2014
First posted: Aug 30, 2010
Registry last updated: Feb 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed