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Safety and Tolerability Study of Levetiracetam to Treat Patients With Status Epilepticus

NCT ID: NCT00362141

Last Updated: 2007-04-02

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-04-30

Brief Summary

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The purpose of this study is to determine whether levetiracetam is safe and well tolerated by patients while suffering a status epilepticus. Levetiracetam is added to the standard treatment of patients with this disease.

Detailed Description

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Status epilepticus (SE) is a disorder with high mortality and morbidity. There are strong indications that ongoing seizure activity substantially reduces the chances on a good outcome. This implies that optimal treatment of SE should start as soon as possible. Unfortunately, treatment options are limited and often based on little evidence. Besides, current treatment options are hampered by serious side-effects like respiratory depression and impaired consciousness. Therefore, the advent of new and effective anti-epileptic drugs (AEDs) is of great potential interest for the treatment of SE. Presently, the newer AEDs are mainly used in later stages of SE at a time when the disease is often more difficult to control. The characteristics of one of these recently introduced anticonvulsants i.e. levetiracetam seems to provide a number of fortunate properties for application as first-line treatment of SE. The complicating side-effects of "classical" AEDs, like a decrease in cardiorespiratory function or in level of consciousness are hardly present. Besides, levetiracetam may lower the need for benzodiazepines, reducing chances on respiratory depression by benzodiazepines at higher doses. Due to a remarkable synergism with first-line administered benzodiazepines, levetiracetam may therefore reduce the need for intubation or ICU treatment. Besides, it may enhance the immediate cessation of seizures, prolong the anti-seizure activity of benzodiazepines and provide neuroprotective properties. The sustained efficacy of levetiracetam would suggest that long term sequelae secondary to neurological damage, may also be reduced. Levetiracetam IV has recently been shown to be safe in healthy volunteers, and becomes available for iv application in clinical practice, early 2006. To date, there are hardly any data available on its applicability in medical emergencies like SE. We propose as a first step the executing of a phase II study on tolerability and safety of intravenous levetiracetam in patients with SE. Current first-line treatment of SE consists of standardized administration of benzodiazepines. For the study we propose to apply this regimen together with the iv administration of levetiracetam as add-on therapy.

Conditions

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Status Epilepticus

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 (add-on)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age: ≥18 years of age
* All types of SE, diagnosed by the medical examiner according to the predefined definition. Absence SE has to be confirmed by EEG.
* Woman: 18-50 years of age of whom is known, from anamnesis or hetero-anamnesis (first line relative), that she is not pregnant.

Exclusion Criteria

* Woman \< 50 years of age, without information on pregnancy
* Known pregnancy
* Known allergy for levetiracetam
* Daily dose levetiracetam of more than 2000mg/day
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role collaborator

Medical Center Haaglanden

OTHER

Sponsor Role lead

Principal Investigators

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Charles Vecht, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical Centre Haaglanden

Locations

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Medical Centre Haaglanden

The Hague, South Holland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Charles Vecht, MD

Role: CONTACT

[email protected]
+31-70-3302508

Joris Uges, Pharmacist

Role: CONTACT

[email protected]
+31-70-3217217

Facility Contacts

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Joris Uges, Pharmacist

Role: primary

[email protected]
+31-70-3217217

Erik Wilms, Pharm D

Role: backup

[email protected]
+31-70-3303131

Related Links

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http://www.ccmo-online.nl

CCMO

Other Identifiers

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METC 06-013

Identifier Type: -

Identifier Source: secondary_id

06-013

Identifier Type: -

Identifier Source: org_study_id