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
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 571
- 试验地点
- 44
- 主要终点
- The percentage of subjects recovering from aphasia as per the Frenchay Aphasia Screening Test (FAST) score at Day 84
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adults ≥ 50 years
- •Considered as reliable and mentally capable of adhering to the protocol
- •Signed informed consent (by the subject or the next of kin) or inclusion of the subject as per Ethics Committee approved procedures
- •Clinical diagnosis of a middle cerebral artery ischemic stroke
- •A disabling motor deficit at the moment of inclusion, defined as having a total Middle Cerebral Artery (MCA) score between 15 and 65
- •Treated before 7 h (6 h and 59 minutes) after the estimated stroke onset
- •If the subject had a stroke during the night, the onset of stroke is assumed to be the last time the subject was seen awake and normal, or last time the subject remembered he/she was awake and normal
- •Being aphasic, defined as having an Aphasia Severity Rating (ASR) score of < 3
排除标准
- •Stupor or coma: < 10 on the item consciousness of the Middle Cerebral Artery (MCA) scale
- •A previous stroke with clinical sequel or a previous stroke with aphasia (even in case of complete recovery from aphasia)
- •A medical or neurological disease interfering with the assessments and causing a clear deficit:
- •in functional ability or autonomy
- •in motor function
- •in cognitive capacities
- •in language
- •A systemic disease with neurological symptoms
- •A life threatening disease with life expectancy of less than 1 year
- •Renal insufficiency (creatinine > 2 mg/100 ml or > 180 µmol/l; creatinine had to be determined as soon as possible but not before inclusion)
- •Any concomitant treatments that could not be stopped at the moment of inclusion or that had been started after the onset of the stroke and before inclusion (as long as not considered by the advisory board as effective drug), such as:
- •Cerebro-vascular active products: bufenine, buflomedil, cinnarizine, codergocrinemesilate, citicholine, cyclandelate, cyprodemanol, deanolacetamidobenzoate, flunarizine, ginkgo-biloba extr., inositolnicotinate, isoxsuprine, meclofenoxate, naftidrofuryloxalate, nicergoline, nicotinic acid (smoking is allowed), nimodipine, pentifylline, papaverine, pentoxifylline, piracetam, pyrisuccideanoldimaleate, pyritinol, raubasine, vincamine, viquidil, xantinolnicotinate. A list of these drugs with generic and brand name, adapted to each of the participating countries accompanied the Case Report Form (CRF)
- •Thrombolytics: recombinant tissue-type plasminogen activator (alteplase) (rt- PA), streptokinase, urokinase, ancrod
- •Hemodilution
- •Glucose infusion >5 %
- •Subjects known to not being able to be followed for 12 weeks
- •Known alcohol or drug addiction or abuse
- •Subjects previously enrolled in this trial
- •Known allergy/intolerance to piracetam/excipients
- •Lactation, pregnancy, or pregnancy potential, unless using an effective means of contraception
- •Illiterate subjects (subjects not able to read prior to stroke)
研究组 & 干预措施
Piracetam
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)
干预措施: Piracetam (Drug)
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.
干预措施: Placebo (Other)
结局指标
主要结局
The percentage of subjects recovering from aphasia as per the Frenchay Aphasia Screening Test (FAST) score at Day 84
时间窗: 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.
次要结局
- Middle Cerebral Artery infarction scale (MCA) score at Day 84(Day 84)
- Total Barthel Index (BI) score at Day 84(Day 84)
- Mini Mental State Examination (MMSE) score at Day 84(Day 84)