A Study to Evaluate the Efficacy and Safety of Piracetam on Aphasia After Acute Ischemic Cerebral Artery Stroke
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.
Acute Ischaemic Middle Cerebral Artery Stroke
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||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|
- The percentage of subjects recovering from aphasia as per the Frenchay Aphasia Screening Test (FAST) score at Day 84 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
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.
- Middle Cerebral Artery infarction scale (MCA) score at Day 84 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]The MCA was developed for clinical trial evaluation of middle cerebral artery stroke. The scale evaluates 10 items: consciousness, verbal communication, elevation of the arm, finger and thumb movements, arm tone, deviation of head and eyes, facial movements, elevation of the leg, dorsiflexion of the foot and leg tone. Weighted scores for each item provide a maximum score of 100.
- Total Barthel Index (BI) score at Day 84 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
This scale evaluates 10 items: eating, moving from (wheel) chair to bed and back, personal hygiene, using the lavatory, bathing, walking/wheelchair, stairs, getting dressed/undressed, controlling bowel motion, controlling bladder.
Weighted scores for each item vary between 0 and 15 to provide a maximum score of 100. Subjects who can perform all specified activities without help receive a score of 100. Even though they are independent in daily activities, they could remain handicapped by neurologic impairments.
- Mini Mental State Examination (MMSE) score at Day 84 [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
The MMSE is divided into two sections, the first of which requires vocal responses only and covers orientation, memory and attention: the maximum score is 21.
The second part tests ability to name, follow verbal and written commands, write a sentence spontaneously and copy a complex polygon: the maximum score is 9. Maximum score of the two parts is 30. The test is not timed. A score ≤ 23 indicates that the subject is demented.
|Study Start Date:||August 1998|
|Study Completion Date:||July 2001|
|Primary Completion Date:||July 2001 (Final data collection date for primary outcome measure)|
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 Comparator: Placebo
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.
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.
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|Study Director:||UCB Clinical Trial Call Center||+1 877 822 9493|