Trial Review

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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 1700 0
Condition category
Condition code
Neurological 1793 1793 0 0
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] 1633 0
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] 2512 0
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] 2512 0
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] 4325 0
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] 4325 0
Secondary outcome [2] 4326 0
Significant medication interaction of intravenous levetiracetam compared with intravenous phenytoin.
Timepoint [2] 4326 0

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?
No
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
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1943 0
Self funded/Unfunded
Name [1] 1943 0
Professor Mark Cook
Country [1] 1943 0
Funding source category [2] 1944 0
Commercial sector/Industry
Name [2] 1944 0
UCB Pharma
Country [2] 1944 0
Primary sponsor type
Individual
Name
Professor Mark Cook
Address
Country
Secondary sponsor category [1] 1757 0
None
Name [1] 1757 0
N/A
Address [1] 1757 0
Country [1] 1757 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3622 0
St Vincent's Health-St Vincent's Hospital Melbourne
Ethics committee address [1] 3622 0
Ethics committee country [1] 3622 0
Australia
Date submitted for ethics approval [1] 3622 0
Approval date [1] 3622 0
Ethics approval number [1] 3622 0

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 27567 0
Address 27567 0
Country 27567 0
Phone 27567 0
Fax 27567 0
Email 27567 0
Contact person for public queries
Name 10822 0
Dr Karen Fuller
Address 10822 0
Level 5 Daly Wing, St Vincent's Hospital, 35 Victoria Pde, Fitzroy, VIC 3065
Country 10822 0
Australia
Phone 10822 0
03 9288 3340
Fax 10822 0
03 9288 3350
Email 10822 0
karen.fuller@svhm.org.au
Contact person for scientific queries
Name 1750 0
Dr Karen Fuller
Address 1750 0
Level 5 Daly Wing
St Vincent's Hospital
35 Victoria Pde
Fitzroy VIC 3065
Country 1750 0
Australia
Phone 1750 0
03 9288 3340
Fax 1750 0
03 9288 3350
Email 1750 0
karen.fuller@svhm.org.au

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
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Documents added automatically
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