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

NCT01546688 Phase 4 TERMINATED Results posted

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).

Details

Lead sponsor	Eisai Limited
Phase	Phase 4
Status	TERMINATED
Enrolment	41
Start date	2008-11
Completion	2011-08

Conditions

• Epilepsy

Interventions

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

Primary outcomes

• Change From Baseline in CVST of the FePsy Test (Mean Reaction Time) by Visit During Titration and Maintenance Period — Baseline, Week 4, Week 8, Week 12, Week 16
  The Computer Visual Search Task (CVST) of the Ferrum Psyche (FePsy)measured cognition. A decrease from Baseline (negative change value) signifies an improvement in the mean reaction time of CVST.
• Change From Baseline in Bond and Lader Visual Analogue Scale (VAS) Mood Sub-Scores for Sedation by Visit During Titration and Maintenance Period — Baseline, Week 4, Week 8, Week 12, Week 16
  The Bond-Lader mood rating scale measured sedation, with scores ranging from 0 to 100. A high score reflects a high level of sedation.

Countries

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