Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000293369
Ethics application status
Approved
Date submitted
30/05/2008
Date registered
12/06/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intravenous Levetiracetam in the Acute Management of Seizures
Scientific title
Intravenous Levetiracetam in the Acute Management of Seizures in Epilepsy
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute seizures 3216 0
Condition category
Condition code
Neurological 3380 3380 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravenous Levetiracetam will be administered in case of acute seizure (1000 mg over 5 minutes), for 1 dose only. Subjects will be observed and followed-up for the next 24 hrs following intravenous levetiracetam injection. Electroencephalographic recordings will be reviewed and subjects will be asked about adverse effects at 1, 12 and 24 hrs after intravenous administration of the agent.
Intervention code [1] 2957 0
Treatment: Drugs
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4270 0
Termination/Control of acute seizure after intravenous infusion of Levetiracetam 1000 mg over 5 minutes
Timepoint [1] 4270 0
Rapid termination of seizure after giving the medication
Secondary outcome [1] 7206 0
Decrease frequency of seizure occurrence and interictal spikes per hour
Timepoint [1] 7206 0
24 hours following intravenous levetiracetam injection

Eligibility
Key inclusion criteria
Epilepsy patients admitted for pre-surgical work-up at Monash Medical Centre with occurrence of acute seizures during epilepsy monitoring
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who are pregnanat or are considering pregnancy, lactation, moderate to severe renal dysfunction

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3442 0
Commercial sector/Industry
Name [1] 3442 0
UCB Pharma
Country [1] 3442 0
Australia
Primary sponsor type
Individual
Name
Prof. David C. Reutens
Address
Department of Neurosciences
Level 5 Block E
Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168
Country
Australia
Secondary sponsor category [1] 3084 0
Individual
Name [1] 3084 0
Dr. Pilita Valencia
Address [1] 3084 0
Department of Neurosciences
Level 5 Block E
Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168
Country [1] 3084 0
Australia
Other collaborator category [1] 299 0
Individual
Name [1] 299 0
Dr. Yong Chern Lee
Address [1] 299 0
Department of Neurosciences
Level 5 Block E
Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168
Country [1] 299 0
Australia
Other collaborator category [2] 308 0
Individual
Name [2] 308 0
Dr. Simon Bower
Address [2] 308 0
Department of Neurosciences
Level 5 Block E
Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168
Country [2] 308 0
Australia
Other collaborator category [3] 309 0
Individual
Name [3] 309 0
Dr. Udaya Seneviratne
Address [3] 309 0
Department of Neurosciences
Level 5 Block E
Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168
Country [3] 309 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5469 0
Southern Health Human Research Ethics Committee
Ethics committee address [1] 5469 0
Ethics committee country [1] 5469 0
Australia
Date submitted for ethics approval [1] 5469 0
20/12/2007
Approval date [1] 5469 0
18/01/2008
Ethics approval number [1] 5469 0
07203C

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28635 0
Address 28635 0
Country 28635 0
Phone 28635 0
Fax 28635 0
Email 28635 0
Contact person for public queries
Name 11792 0
Prof. David C. Reutens
Address 11792 0
Department of Neurosciences
Level 5 Block E
Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168
Country 11792 0
Australia
Phone 11792 0
+61395942240
Fax 11792 0
+61395946241
Email 11792 0
david.reutens@med.monash.edu.au
Contact person for scientific queries
Name 2720 0
Prof. David C. Reutens
Address 2720 0
Department of Neurosciences
Level 5 Block E
Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168
Country 2720 0
Australia
Phone 2720 0
+61395942240
Fax 2720 0
+61395946241
Email 2720 0
david.reutens@med.monash.edu.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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.