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Conversion to Monotherapy Study With Keppra XR for Partial Seizures

Information source: UCB Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: Keppra XR (Drug); Keppra XR (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: UCB Pharma

Official(s) and/or principal investigator(s):
UCB Clinical Trial Call Center, Study Director, Affiliation: +1 877 822 9493

Summary

The primary objective of this study is to assess the efficacy of two doses of Keppra XR compared with a historical control as the placebo, in the monotherapy treatment of partial onset seizures.

Clinical Details

Official title: A Multi-center, Double-blind, Historical Control, Randomized Conversion to Monotherapy Study With Keppra XR for Treatment of Partial Onset Seizures

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: The Cumulative Exit Rate at 112 Days After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase

Secondary outcome:

The Cumulative Rate of Exit Events, Which Include Discontinuation Due to Exit Criteria, Withdrawal Due to Adverse Events (AE) and Withdrawal Due to Lack of Efficacy, at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase

The Cumulative Rate of Exit Events Due to Any Reasons at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase

The Cumulative Exit Rate at 112 Days for the Keppra XR 1000 mg Group After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase

Eligibility

Minimum age: 12 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female subjects 12 to 75 years of age.

- Subjects must have inadequately controlled partial onset epilepsy.

- Subjects must be experiencing 2 to 40 seizures per 4-week period while being

maintained on one or two standard AED(s) Exclusion Criteria:

- A history of status epilepticus in the 6 months preceding randomization.

- Significant medical, psychiatric or neurological illness.

- Intake of benzodiazepines on more than an occasional basis

- History of previous treatment with levetiracetam or sensitivity to levetiracetam.

Locations and Contacts

Aguascalientes, Mexico

Distrio federal, Mexico

Guadalajara Jalisco, Mexico

Guadalajara, Mexico

Mexico City, Mexico

Monterrey, Mexico

Bialystok, Poland

Gdansk, Poland

Katowice, Poland

Lodz, Poland

Lublin, Poland

Poznan, Poland

Szczecin, Poland

Warszawa, Poland

Kalingrad, Russian Federation

Kazan, Russian Federation

Moscow, Russian Federation

Samara, Russian Federation

St Petersburg, Russian Federation

St. Petersburg, Russian Federation

Yaroslavl, Russian Federation

Dothan, Alabama, United States

Northport, Alabama, United States

Phoenix, Arizona, United States

Little Rock, Arkansas, United States

Bakersfield, California, United States

Jacksonville, Florida, United States

Loxahatchee, Florida, United States

Atlanta, Georgia, United States

Suwanee, Georgia, United States

Winfield, Illinois, United States

Witchita, Kansas, United States

Shreveport, Louisiana, United States

Bethesda, Maryland, United States

Detroit, Michigan, United States

Monterrey, NL, Mexico

Camden, New Jersey, United States

New Brunswick, New Jersey, United States

Buffalo, New York, United States

Cedarhurst, New York, United States

Toledo, Ohio, United States

Tulsa, Oklahoma, United States

Bend, Oregon, United States

Monaca, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Beaufort, South Carolina, United States

Additional Information

Product Information

FDA Safety Alerts and Recalls

Starting date: August 2007
Last updated: August 26, 2014

Page last updated: August 23, 2015

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