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

NCT ID: NCT01191086

Last Updated: 2015-02-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2014-05-31

Brief Summary

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

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Detailed Description

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Conditions

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Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open-label USL255

Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day

Group Type EXPERIMENTAL

USL255

Intervention Type DRUG

Interventions

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USL255

Intervention Type DRUG

Other Intervention Names

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Topiramate extended-release

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Upsher-Smith Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Phoenix, Arizona, United States

Site Status

Ventura, California, United States

Site Status

Gainsville, Florida, United States

Site Status

Gulf Breeze, Florida, United States

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Jacksonville, Florida, United States

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Port Charlotte, Florida, United States

Site Status

Lexington, Kentucky, United States

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Waldorf, Maryland, United States

Site Status

Chesterfield, Missouri, United States

Site Status

St Louis, Missouri, United States

Site Status

Somerset, New Jersey, United States

Site Status

Charlotte, North Carolina, United States

Site Status

Toledo, Ohio, United States

Site Status

Dallas, Texas, United States

Site Status

Temple, Texas, United States

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Milwaukee, Wisconsin, United States

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Buenos Aires, , Argentina

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Córdoba, , Argentina

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Salta, , Argentina

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Villa Nueva, , Argentina

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Bedford Park, , Australia

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Clayton, , Australia

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Fitzory, , Australia

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Heidelberg West, , Australia

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Parkville, , Australia

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Randwick, , Australia

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Woodville, , Australia

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Bruges, , Belgium

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Duffel, , Belgium

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Leuven, , Belgium

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Greenfield Park, , Canada

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Toronto, , Canada

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Santiago, , Chile

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Valdivia, , Chile

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Bonn, , Germany

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Munich, , Germany

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Athens, , Greece

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Thessaloniki, , Greece

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Bangalore, , India

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Dehradun, , India

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Hyderabad, , India

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Mangalore, , India

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Mumbai, , India

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New Delhi, , India

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Ashkelon, , Israel

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Holon, , Israel

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Nahariya, , Israel

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Petah Tikva, , Israel

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Ramat Gan, , Israel

Site Status

Auckland, , New Zealand

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Gdansk, , Poland

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Katowice, , Poland

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Krakow, , Poland

Site Status

Lodz, , Poland

Site Status

Lublin, , Poland

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Warsaw, , Poland

Site Status

Kazan', , Russia

Site Status

Moscow, , Russia

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Saint Petersburg, , Russia

Site Status

Samara, , Russia

Site Status

Tyumen, , Russia

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Yaroslavi, , Russia

Site Status

Cape Town, , South Africa

Site Status

Badalona, , Spain

Site Status

Barakaldo, , Spain

Site Status

Granada, , Spain

Site Status

Madrid, , Spain

Site Status

Valencia, , Spain

Site Status

Countries

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United States Argentina Australia Belgium Canada Chile Germany Greece India Israel New Zealand Poland Russia South Africa Spain

References

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Chung SS, Hogan RE, Blatt I, Lawson P B, Nguyen H, Clark AM, Anders B, Halvorsen MB; PREVAIL OLE Study Group. Long-term safety and sustained efficacy of USL255 (topiramate extended-release capsules) in patients with refractory partial-onset seizures. Epilepsy Behav. 2016 Jun;59:13-20. doi: 10.1016/j.yebeh.2016.03.005. Epub 2016 Apr 14.

Reference Type DERIVED
PMID: 27084978 (View on PubMed)

Other Identifiers

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P09-005

Identifier Type: -

Identifier Source: org_study_id

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