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.
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.
Trial Stopped: This study was terminated after a pre-specified interim analysis. Please see Detailed Study Description for further information.
- Piracetam (Nootropil®)Drug
ARM 1: Kind: Experimental Label: Piracetam Description: IV infusion 12 g piracetam in 60 ml IV Ampoules 3 g piracetam in 15 ml Oral solution 33 % piracetam (bottle of 125 ml) Oral tablets 1200 mg piracetam (blisters of 10 tablets)
- Placebo Drug
ARM 1: Kind: Experimental Label: Placebo Description: IV infusion 12 g placebo in 60 ml IV Ampoules 3 g placebo in 15 ml Oral solution 33% placebo (bottle of 125 ml) Oral tablets 1200 mg placebo (blisters of 10 tablets) All IV forms were identical in presentation, size and color to allow a double blind design. All oral forms were identical in shape, size, color and taste to allow a double blind design.
- Allocation: Randomized
- Masking: Double Blind (Subject, Investigator)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||The percentage of subjects recovering from aphasia as per the Frenchay Aphasia Screening Test (FAST) score at Day 84||Day 84||No|
|Secondary||Middle Cerebral Artery infarction scale (MCA) score at Day 84||Day 84||No|
|Secondary||Total Barthel Index (BI) score at Day 84||Day 84||No|
|Secondary||Mini Mental State Examination (MMSE) score at Day 84||Day 84||No|