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Perispinal Etanercept to improve STroke Outcomes (PESTO): Protocol for a multicenter, international, randomized placebo-controlled trial.
Thijs, Vincent; Cloud, Geoffrey C; Gilchrist, Nigel; Parsons, Brooke; Tilvawala, Forum; Ho, Jan; Ruthnam, Lara; Stanislaus, Vimal; Sprigg, Nikola; Walker, Marion; Bath, Philip M; Churilov, Leonid; Bernhardt, Julie.
Afiliación
  • Thijs V; Florey Institute of Neuroscience and Mental Health, University of Melbourne, Heidelberg, VIC, Australia.
  • Cloud GC; Department of Neurology, Austin Health, Heidelberg, VIC, Australia.
  • Gilchrist N; Department of Medicine, Melbourne Medical School, University of Melbourne, Heidelberg/Parkville, VIC Australia.
  • Parsons B; Department of Neuroscience, Central Clinical School, Monash University Melbourne, Melbourne, VIC, Australia.
  • Tilvawala F; Department of Neurology, Alfred Health, Melbourne, VIC, Australia.
  • Ho J; CGM Research Trust, Christchurch, New Zealand.
  • Ruthnam L; Florey Institute of Neuroscience and Mental Health, University of Melbourne, Heidelberg, VIC, Australia.
  • Stanislaus V; Department of Neurology, Austin Health, Heidelberg, VIC, Australia.
  • Sprigg N; Department of Neurology, Austin Health, Heidelberg, VIC, Australia.
  • Walker M; Department of Neurology, Austin Health, Heidelberg, VIC, Australia.
  • Bath PM; Department of Neuroscience, Central Clinical School, Monash University Melbourne, Melbourne, VIC, Australia.
  • Churilov L; Department of Neurology, Alfred Health, Melbourne, VIC, Australia.
  • Bernhardt J; Stroke Trials Unit, Mental Health & Clinical Neuroscience, University of Nottingham, Nottingham, UK.
Eur Stroke J ; 9(3): 789-795, 2024 Sep.
Article en En | MEDLINE | ID: mdl-38676623
ABSTRACT
RATIONALE A large proportion of stroke survivors will have long-lasting, debilitating neurological impairments, yet few efficacious medical treatment options are available. Etanercept inhibits binding of tumor necrosis factor to its receptor and is used in the treatment of inflammatory conditions. Perispinal subcutaneous injection followed by a supine, head down position may bypass the blood brain barrier. In observational studies and one small randomized controlled trial the majority of patients showed improvement in multiple post stroke impairments.

AIM:

Perispinal Etanercept to improve STroke Outcomes (PESTO) investigates whether perispinal subcutaneous injection of etanercept improves quality of life and is safe in patients with chronic, disabling, effects of stroke. METHODS AND

DESIGN:

PESTO is a multicenter, international, randomized placebo-controlled trial. Adult participants with a history of stroke between 1 and 15 years before enrollment and a current modified Rankin scale between 2 and 5 who are otherwise eligible for etanercept are randomized 11 to single dose injection of etanercept or placebo. STUDY

OUTCOMES:

The primary efficacy outcome is quality of life as measured using the Short Form 36 Health Inventory at day 28 after first injection. Safety outcomes include serious adverse events. SAMPLE SIZE TARGET A total of 168 participants assuming an improvement of the SF-36 in 11% of participants in the control arm and in 30% of participants in the intervention arm, 80% power and 5% alpha.

DISCUSSION:

PESTO aims to provide level 1 evidence on the safety and efficacy of perispinal etanercept in patients with long-term disabling effects of stroke.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Calidad de Vida / Accidente Cerebrovascular / Etanercept Límite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Eur Stroke J Año: 2024 Tipo del documento: Article País de afiliación: Australia Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Calidad de Vida / Accidente Cerebrovascular / Etanercept Límite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Eur Stroke J Año: 2024 Tipo del documento: Article País de afiliación: Australia Pais de publicación: Reino Unido