Trial to Evaluate the Safety and Efficacy of Keppra After Conversion to Mono-therapy in Subjects With Partial 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

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2004-07-31

Brief Summary

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A cohort of patients who became seizure-free during add-on treatment to one standard AED with Keppra in a previous trial (N01031) were followed to assess whether seizure freedom was maintained. Tolerability was documented.

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

* Diagnosis of epilepsy with partial seizures;
* having completed the trial N01031 of Keppra as adjunctive therapy (SKATE);
* seizure-free over the last 3 months prior to protocol Visit 1;
* 1 concomitant marketed AED at the time of trial entry and throughout the previous trial N01031;
* on the clinical judgment of the Investigator, progressive withdrawal of the concomitant AED and conversion to monotherapy with Keppra can be attempted.

Exclusion Criteria

* History of suicide attempt, current suicidal ideation, or other serious psychiatric disorders requiring or having required hospitalization or medication within the previous 5 years;
* presence of known pseudoseizures within the last year;
* presence or history of allergy to the components of Keppra (levetiracetam, lactose, cornstarch, and excipients) or other pyrrolidine derivatives;
* felbamate with less than 18 months exposure;
* vigabatrin, without visual field assessment as per recommendation of the manufacturer, i.e., every 6 months;
* uncountable seizures (clusters) or history of convulsive status epilepticus within the last 5 years.

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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N01037

Identifier Type: -

Identifier Source: org_study_id