A double blind, randomised, placebo-controlled, mulitcentre study to assess the efficacy and safety of adjunctive zonisamide in primary generalised tonic clonic seizures.

Phase 3

• Conditions: epilepsy; Neurological - Epilepsy

• Registration Number: ACTRN12608000096358
• Lead Sponsor: Eisia G.C.D., Eisai Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-02-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

primary generalized tonic clonic seizures

Exclusion Criteria

any other type of epilepsy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
decrease of seizure frequency[after 16 weeks of active therapy]

Secondary Outcome Measures

Name	Time	Method
safety - blood samples will be taken and assessed for safety laboratory values.[At screening and final visit (after 16 weeks of active therapy)]