europsychiatric, Neurocognitive And Quality Of Life Outcomes In Patients With Epilepsy Treated With Levetiracetam (Keppra) Verses Older AEDs As First Substitution Monotherapy.

Phase 4

Recruiting

• Conditions: Epilepsy; Neurological - Epilepsy

• Registration Number: ACTRN12606000102572
• Lead Sponsor: Associate Prof. Terence O'Brien and RMH Neurosciences Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-03-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Patients with Epilepsy (except for primary generalised epilepsy), who have failed treatment with their first anti epileptic drug.

Exclusion Criteria

Patients with Primary generalised epilepsy, and patients with major psychiatric morbidity, substance abuse, intellectual disability (inability to consent), and those women plannning pregnancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Proportion of patients who show improvement in anxiety scores, by treatment group (improvement’ is defined as 12 week score < baseline score on HADS)[From baseline to 12 weeks.];2. Proportion of patients who show improvement in QOL (Quality of Life) based on QOLIE-89 scores by treatment group[From baseline to 12 weeks.]

Secondary Outcome Measures

Name	Time	Method
eurocognitive[At 12 and 52 weeks.];Neuropsychiatric[At 12 and 52 weeks.];QOL[At 12 and 52 weeks.];Seizure control[At 12 and 52 weeks.];Retention rates[At 12 and 52 weeks.]