NCT02170077

A Placebo-controlled Study to Investigate Safety and Efficacy of BIA 2-093

A Placebo-controlled Study to Investigate Safety and Efficacy of BIA 2-093 in Controlling Refractory Partial Seizures When Added to Ongoing Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy of BIA 2 093 in the treatment of epileptic patients with refractory simple or complex partial seizures with or without secondary generalization.

Detailed description

This clinical trial was performed as a multicentre, add-on, double-blind, randomised, placebo-controlled, phase II study. During the double-blind treatment phase (12 weeks) patients were assigned to three treatment groups receiving BIA 2 093 once daily (ODG - once-daily group), BIA 2 093 twice daily (TDG - twice-daily group) or placebo (PLG - placebo group), respectively. Daily doses of BIA 2 093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg). On completion of the 12-week double-blind treatment period, a 1-week tapering period was scheduled.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	BIA 2-093	BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route
DRUG	Placebo	Placebo tablets administered orally

Timeline

• Start date: 2002-04-01
• Primary completion: 2002-11-01
• Completion: 2002-11-01
• First posted: 2014-06-23
• Last updated: 2017-08-18
• Results posted: 2014-08-12

Locations

1 site across 1 country: Portugal