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
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
[email protected]
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
[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.