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Bridging Study of L059 (Levet...

Bridging Study of L059 (Levetiracetam) in Patients With Epilepsy by Double Blind Method

Last Updated: 2013-09-17

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

PHASE2

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2003-07-31

Brief Summary

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Double-blind, randomized, placebo-controlled, multi center trial to evaluate the efficacy and safety of levetiracetam as adjunctive treatment in adult Japanese epileptic subjects with partial onset seizures.

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Detailed Description

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Conditions

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Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Levetiracetam

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* simple and/or complex partial seizures with or without secondary generalization, and first partial seizure \>= 2 years before selection visit;
* seizures classifiable according to the ILAE classification;
* minimum of 12 partial seizures per 12 weeks with a minimum of two partial seizures per 4 weeks from the selection visit to the end of the baseline period ;
* exposed to two or more standard AEDs;
* taking up to three of the standard AEDs, at the initiation of the trial.

Exclusion Criteria

* medication influencing the CNS, except for medication taken for antiepileptic treatment;
* partial seizures uncountable due to clustering, including status epileptics, during the 3 months prior to the selection visit;
* history of cerebrovascular disease including transient ischemic attack (TIA) and progressive cerebral disorder or progressive neurological disorder;
* presence or history of any clinically significant allergic condition and complication or history of significant alcohol abuse or drug abuse in the past.

Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers