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Trial registered on ANZCTR

Registration number

ACTRN12607000182493

Ethics application status

Not yet submitted

Date submitted

5/03/2007

Date registered

26/03/2007

Date last updated

26/03/2007

Type of registration

Prospectively registered

Titles & IDs

Public title

Comparison of the safety, tolerability, and efficacy, of levetiracetam versus phenytoin when administered intravenously to an inpatient population at risk for seizures.

Scientific title

Intravenous levetiracetam compared with intravenous phenytoin: an observational study to monitor side effect profile, efficacy by number of seizures, and tolerability in an inpatient population.

Universal Trial Number (UTN)

Trial acronym

N/A

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Seizures

Condition category

Condition code

Neurological

Other neurological disorders

Intervention/exposure

Study type

Observational

Patient registry

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

We observe an inpatient population with the administration of the following interventions: Provision of intravenous levetiracetam at 500mg twice daily for three days followed by oral formulation 500 mg twice daily or as titrated to need for three months, to patients requiring in-hospital, targeted, seizure prophylaxis, to 40 patients.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

The comparator will be 40 patients of similar medical profile, treated with the current standard therapy, intravenous phenytoin 500mg intravenously for three days followed by oral formulation 300mg daily or as titrated to need, for three months.

Control group

Outcomes

Primary outcome [1]

Tolerability of intravenous levetiracetam compared with intravenous phenytoin, based on clinical indicators of side effects (eg. skin rash, muscle fatigue, drowsiness, mood change, liver function abnormality)

Timepoint [1]

At three days after commencement of therapy, on discharge from hospital (variable time base) and at three months after commencement of therapy.

Secondary outcome [1]

Seizure control conferred by intravenous levetiracetam compared with intravenous phenytoin, and significant medication interaction at three days after commencement of therapy, at discharge from hospital (variable time base) and at three months after commencement of therapy.

Timepoint [1]

Secondary outcome [2]

Significant medication interaction of intravenous levetiracetam compared with intravenous phenytoin.

Timepoint [2]

Eligibility

Key inclusion criteria

Hospital inpatient requiring intravenous seizure prophylaxis.Ability to give consent, or availability of responsible person to give consent, or satisfaction of criteria for "procedural authorisation" in the absence of the above.

Minimum age

17 Years

Maximum age

Not stated

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Known intolerance to both levetiracetam and phenytoin.Pregnancy, or risk of pregnancyInability to obtain consent and not satisfying criteria for inclusion by "procedural authorisation".

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/04/2007

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Professor Mark Cook

Address [1]

Country [1]

Funding source category [2]

Commercial sector/Industry

Name [2]

UCB Pharma

Address [2]

Country [2]

Primary sponsor type

Individual

Name

Professor Mark Cook

Address

Country

Secondary sponsor category [1]

None

Name [1]

N/A

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

St Vincent's Health-St Vincent's Hospital Melbourne

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Brief Lay Summary of the Project:
This study concerns the safety and tolerability of the intravenous form of levetiracetam, when compared with standard available therapy.
In the hospital setting, people at risk for seizures may not be able to take medication by mouth to prevent the seizures, and so may need to be given a medication to prevent seizures by another route, most often directly into the vein (intravenously).  A given patient may respond to one seizure preventing medication, but not so readily to another, and such specific response cannot readily be predicted. Also, a particular patient may not be able   to take a particular medication safely, because of side effects with that medication in the past, or because they are taking other medications which do not mix with it.  It is best that ongoing regular tablet medication and any intravenous medication a patient is given to stop seizures from happening, be the same drug known to work for that person. So it would be best to have a range or choice of intravenous seizure preventing medications to cover different patients’ needs, like there is with tablets now. These intravenous medications would need to be tested against each other to see whether they are as safe as medications already being used for the same thing, also to make sure that they work as well as the other medications, and to see whether certain people would benefit more from some medications than others.
Until very recently, there has been little choice in seizure preventing medication to give intravenously in Australia. The mainstays have been benzodiazepine medications (which are not generally used longterm for seizure prevention, and cause drowsiness); and phenytoin , which can be continued as a tablet. Phenytoin generally works well for preventing seizures, but may have side effects, which can be serious, and must be given carefully, at just the right dose and speed. Levetiracetam is a newer seizure prevention medication, which has been widely used in tablet form, which can now be given in another form directly into  the  bloodstream by injection or 'drip' into the vein. It is the only specific seizure preventing drug available for intravenous use in Australia apart from phenytoin.  Given in tablet form, levetiracetam has been shown to be very good  at preventing seizures, has few side effects which generally are mild, and does not seem to interact with other medications that patients might be taking.
This study aims to assess whether the intravenous levetiracetam medication has less side effects than the intravenous phenytoin, while working just as well to prevent seizures. Little difference is expected in the ability of the two drugs to prevent seizures, as they are both known to be very effective.
Patients in hospital who need intravenous seizure preventing medication will be given an effective medication, either phenytoin or levetiracetam, for as long as they need it. This would usually be followed by at least three months of treatment with the same medication by mouth. Side effects and seizure frequency, will be recorded at three intervals – three days after starting medication, on leaving hospital, and three months after leaving hospital. The patient's treating doctors will make all the medical decisions regarding the patient's care, even if that means a patient has to stop the study. The results will be statistically analysed to compare the results for the two medication. In this way, the project hopes to tell whether levetiracetam is as safe and effective as phenytoin, when given intravenously to these types of patients.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Karen Fuller

Address

Level 5 Daly Wing, St Vincent's Hospital, 35 Victoria Pde, Fitzroy, VIC 3065

Country

Australia

Phone

03 9288 3340

Fax

03 9288 3350

[email protected]

Contact person for scientific queries

Name

Dr Karen Fuller

Address

Level 5 Daly Wing
St Vincent's Hospital
35 Victoria Pde
Fitzroy VIC 3065

Country

Australia

Phone

03 9288 3340

Fax

03 9288 3350

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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