Open Label Safety and Efficacy Study of Levetiracetam in Korean Patients With 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

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2004-10-31

Brief Summary

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A Korean open-label, community-based trial assessing the efficacy and safety of levetiracetam as adjunctive therapy in partial epilepsy.

Similarity with a similar study conducted in Caucasian epileptic subjects will be assessed.

Detailed Description

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Conditions

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Epilepsy, Partial

Keywords

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Epilepsy Partial Onset Seizures Keppra Levetiracetam

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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Levetiracetam

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with epilepsy experiencing partial seizures, whether or not secondarily generalized.
* Subjects must present between 3 and 42 partial seizures over the three months prior to protocol Visit 1.
* Use of one (1), but no more than two (2) concomitant marketed AEDs at the time of trial entry.

Exclusion Criteria

* Subjects on felbamate with less than 18 months exposure.
* Subjects on vigabatrin, whose visual field has not been assessed as per recommendation of the manufacturer, i.e. every 6 months.
* Presence of known pseudoseizures within the last year.
* Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors.
* Uncountable seizures (clusters) or history of convulsive status epilepticus within the last five years.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

UCB Pharma

References

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Heo K, Lee BI, Yi SD, Huh K, Kim JM, Lee SA, Shin DJ, Song HK, Lee SK, Kim JY, Lu S, Dubois C, Tonner F. Efficacy and safety of levetiracetam as adjunctive treatment of refractory partial seizures in a multicentre open-label single-arm trial in Korean patients. Seizure. 2007 Jul;16(5):402-9. doi: 10.1016/j.seizure.2007.02.011. Epub 2007 Mar 19.

Reference Type RESULT

PMID: 17369059 (View on PubMed)

Other Identifiers

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N01099

Identifier Type: -

Identifier Source: org_study_id