scholarly journals High-dose albumin treatment for acute ischaemic stroke (ALIAS) part 2: a randomised, double-blind, phase 3, placebo-controlled trial

2013 ◽  
Vol 12 (11) ◽  
pp. 1049-1058 ◽  
Author(s):  
Myron D Ginsberg ◽  
Yuko Y Palesch ◽  
Michael D Hill ◽  
Renee H Martin ◽  
Claudia S Moy ◽  
...  
Keyword(s):  
Ischaemic Stroke ◽  
Acute Ischaemic Stroke ◽  
Controlled Trial ◽  
High Dose ◽  
Phase 3 ◽  
Double Blind

scholarly journals Safety and efficacy of sonothrombolysis for acute ischaemic stroke: a multicentre, double-blind, phase 3, randomised controlled trial

2019 ◽  
Vol 18 (4) ◽  
pp. 338-347 ◽  
Author(s):  
Andrei V Alexandrov ◽  
Martin Köhrmann ◽  
Lauri Soinne ◽  
Georgios Tsivgoulis ◽  
Andrew D Barreto ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Ischaemic Stroke ◽  
Acute Ischaemic Stroke ◽  
Controlled Trial ◽  
Phase 3 ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Randomised Controlled

scholarly journals Efficacy and safety of butylphthalide for patients who had acute ischaemic stroke receiving intravenous thrombolysis or endovascular treatment (BAST trial): study protocol for a randomised placebo-controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e045559
Author(s):  
Xuelei Zhang ◽  
Anxin Wang ◽  
Jing Yu Zhang ◽  
Baixue Jia ◽  
Xiaochuan Huo ◽  
...  
Keyword(s):  
Ischaemic Stroke ◽  
Endovascular Treatment ◽  
Functional Outcome ◽  
Acute Ischaemic Stroke ◽  
Controlled Trial ◽  
Intravenous Thrombolysis ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Ischaemic Injury ◽  
Study Results

IntroductionAs a neuroprotective medication, butylphthalide (NBP) may help protect against cerebral ischaemic injury. However, evidence on whether NBP influences the outcomes of patients who had acute ischaemic stroke who are receiving revascularisation treatment is limited. This study aims to evaluate whether additional NBP therapy can improve the functional outcome of patients who receive intravenous recombinant tissue plasminogen activator and/or endovascular treatment (EVT).Methods and analysisThe study will be a randomised, double-blind, placebo-controlled, multiple-centre, parallel group trial. The sample size is estimated at 1200 patients. Eligible patients will be randomised at a 1:1 ratio to receive either NBP or placebo daily for 90 days, which will include 14 days of injections and 76 days of capsules. The first use of NBP/placebo will be started within 6 hours of onset of ischaemic stroke. The primary outcome is the functional outcome as assessed by the 90-day modified Rankin Scale, adjusted for baseline scores on the National Institutes of Health Stroke Scale. The primary safety outcome is the percentage of serious adverse events during the 90 days of treatment. This trial will determine whether NBP medication benefits patients who had acute ischaemic stroke who receive intravenous thrombolysis or EVT.Ethics and disseminationThe protocol was written according to the general ethical guidelines of the Declaration of Helsinki and approved by the Institutional Review Board/Ethics Committee of Beijing Tiantan Hospital, Capital Medical University with approval number KY 2018-003-02. Ethics committees of all participating sites have approved the study . Results of the study will be published in peer-reviewed scientific journals and shared in scientific presentations.Trial registration numberNCT03539445.

Randomised double-blind placebo-controlled trial of thrombolytic therapy with intravenous alteplase in acute ischaemic stroke (ECASS II)

The Lancet ◽  
1998 ◽  
Vol 352 (9136) ◽  
pp. 1245-1251 ◽  
Author(s):  
Werner Hacke ◽  
Markku Kaste ◽  
Cesare Fieschi ◽  
Rüdiger von Kummer ◽  
Antoni Davalos ◽  
...  
Keyword(s):  
Thrombolytic Therapy ◽  
Ischaemic Stroke ◽  
Acute Ischaemic Stroke ◽  
Controlled Trial ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Intravenous Alteplase

scholarly journals Neuroprotection in Acute Ischaemic Stroke

Stroke ◽  
2001 ◽  
Vol 32 (suppl_1) ◽  
pp. 323-323
Author(s):  
Gunther Ladurner
Keyword(s):  
Placebo Group ◽  
Clinical Outcome ◽  
Ischaemic Stroke ◽  
Acute Ischaemic Stroke ◽  
Neuroprotective Effect ◽  
Controlled Trial ◽  
T Test ◽  
Onset Of Action ◽  
Double Blind ◽  
Motor Functions

41 Aim: This multicentre, double-blind, placebo-controlled trial was conducted to assess the efficacy and safety of an adjuvant administration of Cerebrolysin ® (CERE) in patients suffering from acute ischaemic stroke. Methods: Patients with a first acute ischaemic stroke of the middle cerebral artery were randomised to IV therapy either with placebo (n=68) or with CERE 50ml/day (n=78), for 21 days. Both groups were treated also with acetylsalicylic acid 250mg/day PO and pentoxifylline 300mg/day IV. Treatment was initiated within 24h (mean 12.9±8.1h) after onset of first symptoms. Patients were investigated on treatment days 1, 3, 7, 21 and a follow-up investigation was carried out 3 months after start of treatment. Clinical outcome was recorded on the Canadian Neurological Scale (CNS), Barthel Index (BI) and Clinical Global Impressions (CGI). CERE is a peptide preparation with proven neuroprotective (calpain and caspase inhibitor) and neurotrophic action, produced by a standardised enzymatic breakdown of lipid-free brain proteins. Results: Patients in the CERE group showed a significant improvement in motor functions (CNS, section A1) at the end of therapy (t-test p<0.05) when compared to the placebo group. CERE patients treated within 6 hours after onset of stroke showed a significant improvement in the CGI in the acute treatment phase (t-test p<0.05; CERE n=16, placebo n=14). In the subgroup of patients with a right-sided stroke, CERE patients had a significantly better performance in the BI than placebo patients (Mantel-Haenszel test p<0.001). CERE and placebo were well tolerated and safe. Three patients died in the placebo group, and 2 patients in the CERE group. Conclusion: CERE seems to be an effective adjuvant treatment for acute ischaemic stroke. Motor functions were significantly better, and subgroup evaluation showed that early CERE treatment was related to improved clinical outcome. Adjuvant CERE demonstrated a fast onset of action and offered the possibility for an accelerated rehabilitation probably due to its neuroprotective effect. Large clinical trials are needed to confirm these results.

IP 1184. ZX008 (Fenfluramine) in Dravet’s Syndrome: First Results of a Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial

2018 ◽  
Author(s):  
Tilman Polster ◽  
Lieven Lagae ◽  
Joseph Sullivan ◽  
Ulrich Brandl ◽  
Arne Herting ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Phase 3 ◽  
Double Blind ◽  
Double Blind Placebo ◽  
First Results
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