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A Study to Evaluate the Safety and Tolerability and Explore the Efficacy of Zonisamide as add-on Therapy in Elderly Patients With Refractory Partial Seizures

NCT01546688 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2016-01-08

Study results available
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Summary

A two arm, randomized, double-blind study comparing zonisamide with placebo. The zonisamide arm will consist of 100 subjects and the placebo arm of 50 subjects. Study medication will be administered as an add-on treatment to the subject's current 1 or 2 anti-epileptic (AEDs).

Conditions

Interventions

DRUG

Zonisamide at targeted daily doses of 100-500 mg/day

Each group received 2 doses a day (in the morning and evening) during the Titration Period, once a day (in the evening) or BID during the Maintenance Phase, comprising 25 mg, 50 mg, or 100 mg of ZNS capsules

DRUG

Placebo administered to match targeted daily doses of 100-500 mg/day

matching placebo

Sponsors & Collaborators

  • Eisai Limited

    lead INDUSTRY

Principal Investigators

  • Joanna Segieth · Eisai Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2010-11-30
Completion
2011-08-31

Countries

  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Switzerland
  • United Kingdom

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 NCT01546688 on ClinicalTrials.gov