NCT01883011

A Study to Evaluate the Efficacy and Safety of Piracetam on Aphasia After Acute Ischemic Cerebral Artery Stroke

Randomized, Double Blind, Placebo Controlled, Two Parallel Group Study to Evaluate the Efficacy and Safety of Piracetam, 12 g Intravenous (IV) Infusion Within 7 Hour (h) Post Stroke Onset, Followed by 12 g/d for 4 Weeks (IV Ampoules, Oral Solution) and 4.8 g/d for 8 Weeks (Tablets) in Adult Subjects With an Acute Ischemic Middle Cerebral Artery Stroke

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 571 (actual)
• Sponsor: UCB S.A. - Pharma Sector · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study was to confirm the efficacy of piracetam after 12 weeks of treatment on the aphasic status of subjects suffering from aphasia after acute ischemic middle cerebral artery stroke and having received their medication within 7 h post-stroke onset.

Detailed description

An interim analysis was performed, as planned in the protocol, on the primary efficacy measure (Day 84 FAST Score) for aphasic subjects. This interim analysis indicated that there was less than a 20 % chance of showing a 15 % difference between placebo and piracetam at the end of the trial, under the assumption that there was indeed a 15 % difference. Thus, it was the decision of UCB to stop further recruitment into this study.

Conditions

• Acute Ischaemic Middle Cerebral Artery Stroke

Interventions

Type	Name	Description
DRUG	Piracetam
OTHER	Placebo

Timeline

• Start date: 1998-08-01
• Primary completion: 2001-07-01
• Completion: 2001-07-01
• First posted: 2013-06-21
• Last updated: 2013-08-30

Locations

44 sites across 15 countries: Argentina, Austria, Belgium, France, Germany, Greece, Hungary, Italy, Norway, Poland, Singapore, Spain, Sweden, Taiwan, Turkey (Türkiye)