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

TerminadoFase 4ClinicalTrials.gov

ID: NCT01883011Tipo: INTERVENTIONALInicio: 1 de ago de 1998Fin estimado: 1 de jul de 2001

Traducción no disponible, mostrando original

Resumen

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.

Descripción detallada

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.

Elegibilidad

Edad mínima: 50 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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)

Intervenciones

drug

Piracetam

other

Placebo

Ubicaciones

050

Buenos Aires, Argentina

051

Buenos Aires, Argentina

Patrocinadores

PrincipalUCB S.A. - Pharma Sector

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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