Phase II trial of the Sigma-1 receptor agonist cutamesine (SA4503) for recovery enhancement after acute ischemic stroke

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00843989%3A_____%2F14%3AE0104434" target="_blank" >RIV/00843989:_____/14:E0104434 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/61989592:15120/14:33150660

Výsledek na webu

<a href="http://dx.doi.org/10.1161/STROKEAHA.114.005835" target="_blank" >http://dx.doi.org/10.1161/STROKEAHA.114.005835</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1161/STROKEAHA.114.005835" target="_blank" >10.1161/STROKEAHA.114.005835</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Phase II trial of the Sigma-1 receptor agonist cutamesine (SA4503) for recovery enhancement after acute ischemic stroke

Popis výsledku v původním jazyce

BACKGROUND AND PURPOSE: The ?-1 receptor (Sig-1R) agonist cutamesine (SA4503) enhanced functional recovery after experimental stroke with a treatment initiation window of 48 hours and chronic treatment for 28 days. We conducted a phase 2 clinical trial exploring the safety, tolerability, dose range, and functional effects of cutamesine in patients with ischemic stroke. METHODS: Subjects were randomized between 48 and 72 hours after stroke to receive cutamesine 1 mg/d, 3 mg/d, or placebo for 28 days. Effects on safety and function were assessed at baseline, at end of treatment (day 28), and at end of follow-up (day 56). RESULTS: In 60 patients, treatment with both cutamesine dosages was safe and well tolerated without significant differences in numbersof treatment emergent or serious adverse events. No significant effect was observed on the primary efficacy measure (change in National Institutes of Health Stroke Scale from baseline to day 56) or modified Rankin Scale and Barthel Index

Název v anglickém jazyce

Phase II trial of the Sigma-1 receptor agonist cutamesine (SA4503) for recovery enhancement after acute ischemic stroke

Popis výsledku anglicky

BACKGROUND AND PURPOSE: The ?-1 receptor (Sig-1R) agonist cutamesine (SA4503) enhanced functional recovery after experimental stroke with a treatment initiation window of 48 hours and chronic treatment for 28 days. We conducted a phase 2 clinical trial exploring the safety, tolerability, dose range, and functional effects of cutamesine in patients with ischemic stroke. METHODS: Subjects were randomized between 48 and 72 hours after stroke to receive cutamesine 1 mg/d, 3 mg/d, or placebo for 28 days. Effects on safety and function were assessed at baseline, at end of treatment (day 28), and at end of follow-up (day 56). RESULTS: In 60 patients, treatment with both cutamesine dosages was safe and well tolerated without significant differences in numbersof treatment emergent or serious adverse events. No significant effect was observed on the primary efficacy measure (change in National Institutes of Health Stroke Scale from baseline to day 56) or modified Rankin Scale and Barthel Index

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FH - Neurologie, neurochirurgie, neurovědy

OECD FORD obor

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Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2014

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Stroke

ISSN

0039-2499

e-ISSN

—

Svazek periodika

45

Číslo periodika v rámci svazku

n. 11

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

7

Strana od-do

"p. 3304-3310"

Kód UT WoS článku

000344351500039

EID výsledku v databázi Scopus

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