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
Sponsor: UCB S.A. - Pharma Sector
Terminated
This study was terminated after a pre-specified interim analysis. Please see Detailed Study Description for further information.
A PHASE4 clinical study on Acute Ischaemic Middle Cerebral Artery Stroke, this trial is terminated or withdrawn. The trial is conducted by UCB S.A. - Pharma Sector and has accumulated 11 data snapshots since 1998. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)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.
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.
Status Flow
Change History
11 versions recorded-
Jan 2026 — Present [monthly]
Terminated PHASE4
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Sep 2025 — Present [monthly]
Terminated PHASE4
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Sep 2024 — Sep 2025 [monthly]
Terminated PHASE4
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Jul 2024 — Sep 2024 [monthly]
Terminated PHASE4
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Dec 2021 — Jul 2024 [monthly]
Terminated PHASE4
▶ Show 6 earlier versions
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Jan 2021 — Dec 2021 [monthly]
Terminated PHASE4
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Nov 2020 — Jan 2021 [monthly]
Terminated PHASE4
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Jun 2018 — Nov 2020 [monthly]
Terminated PHASE4
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May 2018 — Jun 2018 [monthly]
Terminated PHASE4
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Aug 2017 — May 2018 [monthly]
Terminated PHASE4
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Jan 2017 — Aug 2017 [monthly]
Terminated PHASE4
First recorded
Aug 1998
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- UCB S.A. - Pharma Sector
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Antwerp, Belgium , Athens, Greece , Bergen, Norway , Bialystok, Poland , Brussels, Belgium , Budapest, Greece , Budapest, Hungary , Buenos Aires, Argentina , Charleville-Mézières, France , Debrecen, Hungary and 24 more locations