Monotherapy With Levetiracetam in Patients Suffering From Epilepsy.

NCT ID: NCT00150813

Last Updated: 2018-11-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-10

Study Completion Date

2007-05-29

Brief Summary

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An open-label follow-up trial assessing the long term safety of levetiracetam as per adverse events reporting.

Detailed Description

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Conditions

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Epilepsy, Tonic-clonic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Levetiracetam

Subjects received open-label Levetiracetam.

Group Type EXPERIMENTAL

Levetiracetam

Intervention Type DRUG

Pharmaceutical form: oral tablets Route of administration: Oral use

Interventions

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Levetiracetam

Pharmaceutical form: oral tablets Route of administration: Oral use

Intervention Type DRUG

Other Intervention Names

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Keppra

Eligibility Criteria

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Inclusion Criteria

* Subjects with a confirmed diagnosis of epilepsy.
* Subjects having experienced in the past unprovoked partial seizures (IA, IB, IC with clear focal origin),or generalized tonic-clonic seizures (without clear focal origin), that are classifiable according to the International Classification of Epileptic Seizures
* Subjects having participated in the previous double-blind monotherapy trial (N01061 \[NCT00150735\] or N01093 \[NCT00150787\]).
* Male/female subjects (\>= 16 years).

Exclusion Criteria

\- Need for an additional Antiepileptic Drug (AED).
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Pharma SA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Cares

Role: STUDY_DIRECTOR

001 844 599 2273 (UCB)

Locations

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Beroun, , Czechia

Site Status

Brno, , Czechia

Site Status

České Budějovice, , Czechia

Site Status

Prague, , Czechia

Site Status

Rychnov nad Kněžnou, , Czechia

Site Status

Budapest, , Hungary

Site Status

Debrecen, , Hungary

Site Status

Pécs, , Hungary

Site Status

Szeged, , Hungary

Site Status

Bialystok, , Poland

Site Status

Gdansk, , Poland

Site Status

Katowice, , Poland

Site Status

Lodz, , Poland

Site Status

Lublin, , Poland

Site Status

Szczecin, , Poland

Site Status

Warsaw, , Poland

Site Status

Gothenburg, , Sweden

Site Status

Helsingborg, , Sweden

Site Status

Huddinge, , Sweden

Site Status

Karlstad, , Sweden

Site Status

Uppsala, , Sweden

Site Status

Countries

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Czechia Hungary Poland Sweden

Related Links

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Other Identifiers

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N01127

Identifier Type: -

Identifier Source: org_study_id

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