Clinical trial NCT01883011: A Study to Evaluate the Efficacy and Safety of Piracetam on Aphasia After Acute Ischemic Cerebral Artery Stroke
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Acute Ischaemic Middle Cerebral Artery Stroke
Keywords: Piracetam
Stroke
Aphasia
Acute
Cerebral
Ischemic
Nootropil
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2013-06-21
Enrollment: 571
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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:
* 1. in functional ability or autonomy
* 2. in motor function
* 3. in cognitive capacities
* 4. 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:
* 1. 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)
* 2. Thrombolytics: recombinant tissue-type plasminogen activator (alteplase) (rt- PA), streptokinase, urokinase, ancrod
* 3. Hemodilution
* 4. 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)

Primary outcomes:
measure: The percentage of subjects recovering from aphasia as per the Frenchay Aphasia Screening Test (FAST) score at Day 84
timeFrame: Day 84
Secondary outcomes:
measure: Middle Cerebral Artery infarction scale (MCA) score at Day 84
timeFrame: Day 84
measure: Total Barthel Index (BI) score at Day 84
timeFrame: Day 84
measure: Mini Mental State Examination (MMSE) score at Day 84
timeFrame: Day 84
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: 050
city: Buenos Aires
country: Argentina
facility: 051
city: Inssbruck
country: Austria
facility: 004
city: Linz
country: Austria
facility: 001
city: Linz
country: Austria
facility: 003
city: Antwerpen
country: Belgium
facility: 102
city: Antwerpen
country: Belgium
facility: 103
city: Brussels
country: Belgium
facility: 104
city: Genk
country: Belgium
facility: 107
city: Charleville-Mezieres
country: France
facility: 150
city: Nice cedex 1
country: France
facility: 152
city: Magdeburg
country: Germany
facility: 201
city: Minden
country: Germany
facility: 200
city: Nidda-bad-Salzhausen
country: Germany
facility: 203
city: Saarbrucken
country: Germany
facility: 202
city: Athens
country: Greece
facility: 251
city: Athens
country: Greece
facility: 252
city: Budapest
country: Greece
facility: 302
city: Budapest
country: Greece
facility: 303
city: Budapest
country: Greece
facility: 305
city: Thessaloniki
country: Greece
facility: 250
city: Budapest
country: Hungary
facility: 300
city: Debrecen
country: Hungary
facility: 304
city: Miskolc
country: Hungary
facility: 301
city: Perugia
country: Italy
facility: 350
city: Bergen
country: Norway
facility: 750
city: Bialystok
country: Poland
facility: 455
city: Krakow
country: Poland
facility: 454
city: Lodz
country: Poland
facility: 456
city: Poznan
country: Poland
facility: 451
city: Warsaw
country: Poland
facility: 450
city: Warszawa
country: Poland
facility: 452
city: Singapore
country: Singapore
facility: 600
city: Singapore
country: Singapore
facility: 601
city: Madrid
country: Spain
facility: 501
city: Madrid
country: Spain
facility: 502
city: Malaga
country: Spain
facility: 503
city: Terrassa
country: Spain
facility: 500
city: Stockholm
country: Sweden
facility: 550
city: Taipei
country: Taiwan
facility: 700
city: Edirne
country: Turkey
facility: 654
city: Eskisehir
country: Turkey
facility: 650
city: Istanbul
country: Turkey
facility: 652
city: Istanbul
country: Turkey
facility: 653
Study officials:
affiliation: +1 877 822 9493
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: