Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Partial Seizures

NCT ID: NCT00419393

Last Updated: 2014-09-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2010-03-31

Brief Summary

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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.

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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Keppra XR (Levetiracetam XR)

1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)

Group Type EXPERIMENTAL

Keppra XR (Levetiracetam XR)

Intervention Type DRUG

500 mg tablets, 1000 - 3000 mg/day, flexible dosing for duration of the study (planned: approximately 6 months-3 years).

Interventions

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Keppra XR (Levetiracetam XR)

500 mg tablets, 1000 - 3000 mg/day, flexible dosing for duration of the study (planned: approximately 6 months-3 years).

Intervention Type DRUG

Other Intervention Names

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Keppra XR

Eligibility Criteria

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Inclusion Criteria

* Subjects who were randomized into study N01280 \[NCT00419094\], and completed the 2 week up titration period

Exclusion Criteria

* Subjects who were discontinued prior to the end of titration period
Minimum Eligible Age

12 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Clinical Trial Call Center, MD

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

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Dothan, Alabama, United States

Site Status

Northport, Alabama, United States

Site Status

Phoenix, Arizona, United States

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Little Rock, Arkansas, United States

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Bakersfield, California, United States

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Loxahatchee Groves, Florida, United States

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Atlanta, Georgia, United States

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Suwanee, Georgia, United States

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Witchita, Kansas, United States

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Detroit, Michigan, United States

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Camden, New Jersey, United States

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Buffalo, New York, United States

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Cedarhurst, New York, United States

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Toledo, Ohio, United States

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Tulsa, Oklahoma, United States

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San Antonio, Texas, United States

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Aguascalientes, , Mexico

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Guadalajara, , Mexico

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Guadalajara Jalisco, , Mexico

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Mexico City, , Mexico

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Monterrey, , Mexico

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Bialystok, , Poland

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Gdansk, , Poland

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Katowice, , Poland

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Lodz, , Poland

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Lublin, , Poland

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Poznan, , Poland

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Szczecin, , Poland

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Warsaw, , Poland

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Kalingrad, , Russia

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Kazan', , Russia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Samara, , Russia

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Yaroslavl, , Russia

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Countries

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United States Mexico Poland Russia

Related Links

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Other Identifiers

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2007-000899-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

N01281

Identifier Type: -

Identifier Source: org_study_id

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