NCT01546688

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

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Eisai Limited · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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

• Epilepsy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-11-01
• Primary completion: 2010-11-01
• Completion: 2011-08-01
• First posted: 2012-03-07
• Last updated: 2016-01-08
• Results posted: 2013-02-06

Locations

36 sites across 7 countries: Germany, Hungary, Italy, Netherlands, Poland, Switzerland, United Kingdom