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

Not Applicable

• Conditions: Seizures; Neurological - Other neurological disorders

• Registration Number: ACTRN12607000182493
• Lead Sponsor: Professor Mark Cook

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-03-26
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 80

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.

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

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.[];Significant medication interaction of intravenous levetiracetam compared with intravenous phenytoin.[]