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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: UCB S.A. - Pharma Sector

Current Primary Outcome: The percentage of subjects recovering from aphasia as per the Frenchay Aphasia Screening Test (FAST) score at Day 84 [ Time Frame: 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.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Middle Cerebral Artery infarction scale (MCA) score at Day 84 [ Time Frame: Day 84 ]
    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 ]

    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 ]

    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.



Original Secondary Outcome: Same as current

Information By: UCB Pharma

Dates:
Date Received: June 18, 2013
Date Started: August 1998
Date Completion:
Last Updated: August 28, 2013
Last Verified: August 2013