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

NCT ID: NCT01142193

Last Updated: 2014-05-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

249 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-01-31

Brief Summary

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The purpose of this study is to examine the safety and effectiveness 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

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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USL255

Group Type EXPERIMENTAL

USL255

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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USL255

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subject has a confirmed diagnosis of partial-onset seizures with or without secondary generalization for at least 12 months prior to Visit 1.
* Currently on a stable dosing regimen of 1 to 3 AEDs for at least 4-weeks prior to Visit 1 (12 weeks for phenobarbital and primidone).
* Have a minimum of 8 partial-onset seizures and no more than 21 consecutive seizure free days, during the 8-week baseline.

Exclusion Criteria

* Have a history of seizure episodes lasting less than 30 minutes in which several seizures occur with such frequency that the initiation and completion of each individual seizure cannot be distinguished, within 3 months prior to Visit 1.
* Have a history of pseudoseizures, or status epilepticus, within 3 months prior to Visit 1.
* Have a history of metabolic acidosis, nephrolithiasis, ureterolithiasis, or narrow angle glaucoma.
* Have a history of suicidal attempts, suicidal ideation, or uncontrolled psychiatric illness within 2 years of Visit 1.
* Currently taking, or have taken felbamate within the past 18 months, or have taken vigabatrin in the past.
* Have taken topiramate within the past 6 months.
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

Gainesville, Florida, United States

Site Status

Gulf Breeze, Florida, United States

Site Status

Jacksonville, Florida, United States

Site Status

Pensacola, Florida, United States

Site Status

Port Charlotte, Florida, United States

Site Status

Boise, Idaho, United States

Site Status

Lexington, Kentucky, United States

Site Status

Waldorf, Maryland, United States

Site Status

Chesterfield, Missouri, United States

Site Status

St Louis, Missouri, United States

Site Status

New Brunswick, New Jersey, United States

Site Status

New York, New York, 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

Site Status

Milwaukee, Wisconsin, United States

Site Status

Buenos Aires, , Argentina

Site Status

Córdoba, , Argentina

Site Status

Salta, , Argentina

Site Status

Villa Nueva, , Argentina

Site Status

Bedford Park, , Australia

Site Status

Clayton, , Australia

Site Status

Fitzory, , Australia

Site Status

Heidelberg West, , Australia

Site Status

Parkville, , Australia

Site Status

Randwick, , Australia

Site Status

Woodville, , Australia

Site Status

Bruges, , Belgium

Site Status

Duffel, , Belgium

Site Status

Leuven, , Belgium

Site Status

Greenfield Park, , Canada

Site Status

Santiago, , Chile

Site Status

Valdivia, , Chile

Site Status

Bonn, , Germany

Site Status

München, , Germany

Site Status

Athens, , Greece

Site Status

Thessaloniki, , Greece

Site Status

Budapest, , Hungary

Site Status

Bangalore, , India

Site Status

Dehradun, , India

Site Status

Hyderabad, , India

Site Status

Mangalore, , India

Site Status

New Delhi, , India

Site Status

Ashkelon, , Israel

Site Status

Haifa, , Israel

Site Status

Holon, , Israel

Site Status

Nahariya, , Israel

Site Status

Petah Tikva, , Israel

Site Status

Ramat Gan, , Israel

Site Status

Auckland, , New Zealand

Site Status

Gdansk, , Poland

Site Status

Krakow, , Poland

Site Status

Lodz, , Poland

Site Status

Lublin, , Poland

Site Status

Warsaw, , Poland

Site Status

Kazan', , Russia

Site Status

Moscow, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Samara, , Russia

Site Status

Tyumen, , Russia

Site Status

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

Countries

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

References

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Chung SS, Fakhoury TA, Hogan RE, Nagaraddi VN, Blatt I, Lawson B, Arnold S, Anders B, Clark AM, Laine D, Meadows RS, Halvorsen MB; PREVAIL Study Group. Once-daily USL255 as adjunctive treatment of partial-onset seizures: randomized phase III study. Epilepsia. 2014 Jul;55(7):1077-87. doi: 10.1111/epi.12660. Epub 2014 Jun 5.

Reference Type DERIVED
PMID: 24902983 (View on PubMed)

Hogan RE, Blatt I, Lawson B, Nagaraddi V, Fakhoury TA, Anders B, Clark AM, Laine D, Halvorsen MB, Chung SS. Efficacy of once-daily extended-release topiramate (USL255): a subgroup analysis based on the level of treatment resistance. Epilepsy Behav. 2014 Dec;41:136-9. doi: 10.1016/j.yebeh.2014.09.061. Epub 2014 Oct 21.

Reference Type DERIVED
PMID: 25461205 (View on PubMed)

Other Identifiers

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2009-016996-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P09-004

Identifier Type: -

Identifier Source: org_study_id

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