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

NCT01883011 Phase 4 TERMINATED

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.

Details

Lead sponsor	UCB S.A. - Pharma Sector
Phase	Phase 4
Status	TERMINATED
Enrolment	571
Start date	1998-08
Completion	2001-07

Conditions

• Acute Ischaemic Middle Cerebral Artery Stroke

Interventions

• Piracetam
• Placebo

Primary outcomes

• The percentage of subjects recovering from aphasia as per the Frenchay Aphasia Screening Test (FAST) score at Day 84 — Day 84
  FAST describes the presence, absence or severity of aphasia, but does not differentiate types of aphasia. Comprehension, expression and reading were main score targets tested by picture card with attached reading card. The FAST score covered a range from 0-20. Subjects with FAST score ≤13 where considered as aphasic and subjects with FAST score \> 13 were considered as non-aphasic. There were 2 tests of comprehension and 2 tests of expression and 1 of reading, however the reading test was not included in the primary efficacy variable.

Countries

Argentina, Austria, Belgium, France, Germany, Greece, Hungary, Italy, Norway, Poland, Singapore, Spain, Sweden, Taiwan, Turkey (Türkiye)