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

Information source: Upsher-Smith Laboratories
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: USL255 (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Upsher-Smith Laboratories

Summary

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

Clinical Details

Official 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

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Buenos Aires, Argentina

Cordoba, Argentina

Guaymallen, Argentina

Salta, Argentina

Bedford Park, Australia

Clayton, Australia

Fitzory, Australia

Heidelberg West, Australia

Parkville, Australia

Randwick, Australia

Woodville, Australia

Brugge, Belgium

Duffel, Belgium

Leuven, Belgium

Greenfield Park, Canada

Toronto, Canada

Santiago, Chile

Valdivia, Chile

Bonn, Germany

Munich, Germany

Athens, Greece

Thessaloniki, Greece

Bangalore, India

Dehradun, India

Hyderabad, India

Mangalore, India

Mumbai, India

New Delhi, India

Ashkelon, Israel

Holon, Israel

Nahariya, Israel

Petach Tikva, Israel

Ramat Gan, Israel

Auckland, New Zealand

Gdansk, Poland

Katowice, Poland

Krakow, Poland

Lodz, Poland

Lublin, Poland

Warszawa, Poland

Kazan, Russian Federation

Moscow, Russian Federation

Samara, Russian Federation

St Petersburg, Russian Federation

Tyumen, Russian Federation

Yaroslavi, Russian Federation

Cape Town, South Africa

Badalona, Spain

Baracaldo, Spain

Granada, Spain

Madrid, Spain

Valencia, Spain

Phoenix, Arizona, United States

Ventura, California, United States

Gainsville, Florida, United States

Gulf Breeze, Florida, United States

Jacksonville, Florida, United States

Port Charlotte, Florida, United States

Lexington, Kentucky, United States

Waldorf, Maryland, United States

Chesterfield, Missouri, United States

St Louis, Missouri, United States

Somerset, New Jersey, United States

Charlotte, North Carolina, United States

Toledo, Ohio, United States

Dallas, Texas, United States

Temple, Texas, United States

Milwaukee, Wisconsin, United States

Additional Information

Starting date: October 2010
Last updated: February 9, 2015

Page last updated: August 23, 2015

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