Safety and Efficacy of 333369 in the Treatment of Partial Epilepsy

NCT ID: NCT00228969

Last Updated: 2012-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2006-05-31

Brief Summary

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The primary objective of this study is to evaluate the efficacy, safety, and tolerability of 4 daily doses of RWJ-333369 as adjunctive treatment of refractory partial epilepsy in subjects who are between 18 and 70 years of age, inclusive

Detailed Description

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Conditions

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Refractory Epilepsy

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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RWJ-333369

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age 18-70 years old,
2. Diagnosis of epilepsy for at least 1 year,
3. Presenting, on average, at least 3 partial onset seizures per month,
4. Currently treated with a stable dose (i.e., for at least 4 weeks) of no more than 3 anti-epileptic drugs (AEDs),

Exclusion Criteria

1. Have experienced status epilepticus in the past 3 months,
2. Have any serious diseases,
3. History of major psychiatric disorders within the past 2 years.
4. Have received an experimental drug/device within the past 30 days
5. Are pregnant or breastfeeding.
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SK Life Science, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Birmingham, Alabama, United States

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Huntsville, Alabama, United States

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Mobile, Alabama, United States

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Northport, Alabama, United States

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Phoenix, Arizona, United States

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Little Rock, Arkansas, United States

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Irvine, California, United States

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Northridge, California, United States

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Sacramento, California, United States

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Fort Collins, Colorado, United States

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Wilmington, Delaware, United States

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Decatur, Georgia, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Golden Valley, Minnesota, United States

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Saint Paul, Minnesota, United States

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Chesterfield, Missouri, United States

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Cincinnati, Ohio, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Sellersville, Pennsylvania, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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El Paso, Texas, United States

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Bennington, Vermont, United States

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Charlottesville, Virginia, United States

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Roanoke, Virginia, United States

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Madison, Wisconsin, United States

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Ciudad de Buenos Aires, , Argentina

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Córdoba, , Argentina

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Salta, , Argentina

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Budapest, , Hungary

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Debrecen, , Hungary

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Győr, , Hungary

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Pécs, , Hungary

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Zalaegerszeg-Pozva, , Hungary

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Breda, , Netherlands

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Heemstede, , Netherlands

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Heeze, , Netherlands

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Rotterdam, , Netherlands

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Gdansk, , Poland

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Katowice, , Poland

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Kielce, , Poland

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Krakow, , Poland

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Lublin, , Poland

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Mosina, , Poland

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Warsaw, , Poland

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Zabrze, , Poland

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Moscow, , Russia

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Saint Petersburg, , Russia

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Samara, , Russia

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Barcelona, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Pamplona, , Spain

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Glasgow, , United Kingdom

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Middlesbrough, , United Kingdom

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Northampton, , United Kingdom

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Oxford, , United Kingdom

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Reading, , United Kingdom

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Countries

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United States Argentina Hungary Netherlands Poland Russia Spain United Kingdom

References

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Lu C, Zheng J, Cao Y, Bresnahan R, Martin-McGill KJ. Carisbamate add-on therapy for drug-resistant focal epilepsy. Cochrane Database Syst Rev. 2021 Dec 6;12(12):CD012121. doi: 10.1002/14651858.CD012121.pub2.

Reference Type DERIVED
PMID: 34870321 (View on PubMed)

Other Identifiers

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333369-EPY-2003

Identifier Type: -

Identifier Source: org_study_id