A Phase IV-Pharmacovigilance Study of Keppra Greece - S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy

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

PHASE4

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2004-07-31

Brief Summary

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Patients in community-based practices correspond to the 25% of patients who need a first add-on drug when not controlled by their standard monotherapy drug. This was a therapeutic use trial in which the population corresponds more closely to that seen in daily clinical practice.

Detailed Description

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Conditions

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Epilepsy

Keywords

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Levetiracetam Keppra

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Levetiracetam (Keppra)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* partial onset seizures with or without secondary generalisation with epilepsy.

Exclusion Criteria

* hypersensitivity to levetiracetam or other pyrrolidone derivatives or to any of the excipients.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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UCB

Principal Investigators

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UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Other Identifiers

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N01035

Identifier Type: -

Identifier Source: org_study_id