Pharmacovigilance Study of Keppra. SPAIN - SKATE : 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

342 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2003-05-31

Brief Summary

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Patients with partial-onset seizures seen in community-based practices were to be included in this therapeutic use study

* to assess the safety and tolerability of Keppra (Levetiracetam) and to confirm the favorable safety of the drug found during clinical development
* to obtain further information about optimal dosing in daily clinical practice. Compared to previous registration trials, the study population corresponded more closely to that seen in daily clinical practice.

Detailed Description

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Conditions

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Epilepsy, Partial

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female older than 16 years;
* Epilepsy with partial onset seizures, with or without secondary generalization;
* At least one concomitant marketed anti-epileptic drug

Exclusion Criteria

* Safety reasons

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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N01033

Identifier Type: -

Identifier Source: org_study_id