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Comparing The Effect On Cognition Of Adjunctive Therapy With Zonisamide Versus Sodium Valproate

NCT00713622 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2015-11-03

No results posted yet for this study

Summary

Zonisamide (Zonegran) and sodium valproate (Epilim) are both medicines approved to treat epilepsy. The purpose of this study is to find out the extent to which zonisamide may affect memory and concentration, compared to sodium valproate.

Conditions

Interventions

DRUG

Zonisamide

Capsules of 25mg, 50mg and 100mg zonisamide will be supplied. Dosing will be twice a day.

DRUG

Sodium valproate

Crushable tablets of 100mg and enteric coated tablets of 200mg and 500mg will be supplied. Dosing will start at 600mg/day, increasing to the minimally effective dose, the maximum tolerated dose, or 2500mg/day, whichever is the lowest.

Sponsors & Collaborators

  • Eisai Limited

    lead INDUSTRY

Principal Investigators

  • Andrew Yeates · Eisai Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2008-12-31
Completion
2009-04-30

Countries

  • Austria
  • Finland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00713622 on ClinicalTrials.gov