NCT00272909

Efficacy of SUN N4057 in Subjects With Acute Ischemic Stroke and Measurable Penumbra on Magnetic Resonance Imaging (MRI)

A Phase IIb Randomized, Double-blind, Placebo-Controlled, Group-Sequential, Multicenter, Dose Finding Study of the Safety and Efficacy of SUN N4057 (Piclozotan) Administered for 72 Hours by Continuous Intravenous Infusion in Subjects With Acute Ischemic Stroke and Measurable Penumbra on MRI

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This research study is designed to evaluate the safety, tolerability, and efficacy of SUN N4057 (piclozotan) in subjects with acute ischemic stroke within 9 hours of the onset of symptoms.

Detailed description

The primary objective of the study is to determine the efficacy of a 72 hour infusion of SUN N4057 (piclozotan) in subjects with clinical findings of an acute ischemic stroke and a magnetic resonance imaging (MRI) demonstrating a measurable penumbra (perfusion-weighted imaging \[PWI\] minus diffusion-weighted imaging \[DWI\] volume). Efficacy will be determined by comparing the proportion of subjects with no growth in stroke lesion volume as assessed by DWI at Screening to stroke lesion volume assessed by FLAIR (fluid-attenuated inversion recovery) on Day 28 in the piclozotan group versus the placebo group.

Conditions

• Stroke

Interventions

Type	Name	Description
DRUG	piclozotan low dose	Continuous IV infusion over a period of up to 72 hours of piclozotan
DRUG	placebo	Continuous IV infusion over a period of up to 72 hours of placebo.
DRUG	piclozotan high dose	Continuous IV infusion over a period of up to 72 hours of piclozotan

Timeline

• Start date: 2004-09-01
• Primary completion: 2006-10-01
• Completion: 2007-01-01
• First posted: 2006-01-09
• Last updated: 2015-10-20

Locations

47 sites across 7 countries: United States, Belgium, Germany, Israel, Poland, South Africa, Spain