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Long Term Follow-up Study With Keppra XR (Levetiracetam 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 (Levetiracetam XR) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: UCB Pharma

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

Summary

To provide continued treatment of Keppra XR (Levetiracetam XR) and to assess the long term safety of Keppra XR in subjects with partial onset seizures.

Clinical Details

Official title: An Open-label, Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Treatment of Partial-onset Seizures

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

Primary outcome:

Number of Subjects Who Experienced at Least 1 Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)

Number of Subjects Who Experienced at Least 1 Serious Treatment Emergent Adverse Event During the Actual Treatment Period (6 Months-2 Years)

Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event During the Actual Treatment Period

Secondary outcome:

Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 6 Months

Percentage of Subjects Remaining on Keppra XR Monotherapy From Study Entry Through 12 Months

Eligibility

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

Criteria:

Inclusion Criteria:

- Subjects who were randomized into study N01280 [NCT00419094], and completed the 2

week up titration period Exclusion Criteria:

- Subjects who did not meet the inclusion/exclusion criteria for N01280 [NCT00419094]

- Subjects who were discontinued prior to the end of titration period

Locations and Contacts

Aguascalientes, Mexico

Guadalajara Jalisco, Mexico

Guadalajara, Mexico

Mexico City, Mexico

Mexico DF, 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

Loxahatchee, Florida, United States

Atlanta, Georgia, United States

Suwanee, Georgia, United States

Witchita, Kansas, United States

Detroit, Michigan, United States

Camden, New Jersey, United States

Buffalo, New York, United States

Cedarhurst, New York, United States

Toledo, Ohio, United States

Tulsa, Oklahoma, United States

San Antonio, Texas, United States

Additional Information

FDA Safety Alerts and Recalls

Product Information

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

Page last updated: August 23, 2015

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