A randomized double-blind clinical trial on safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS): the statistical analysis plan of TUDCA-ALS trial

被引：0

作者：

Flavia L. Lombardo

Stefania Spila Alegiani

Flavia Mayer

Marta Cipriani

Maria Lo Giudice

Albert Christian Ludolph

Christopher J. McDermott

Philippe Corcia

Philip Van Damme

Leonard H. Van den Berg

Orla Hardiman

Gabriele Nicolini

Nicola Vanacore

Brian Dickie

Alberto Albanese

Maria Puopolo

机构：

[1] Italian National Institute of Health,National Centre for Disease Prevention and Health Promotion

[2] Italian National Institute of Health,National Center for Drug Research and Evaluation

[3] Sapienza University of Rome,Department of Statistical Sciences

[4] Italian National Institute of Health,Department of Neuroscience

[5] IRCCS Humanitas Research Hospital,Neurology Department

[6] University of Ulm,Neurology Department

[7] Site Ulm,German Centre of Neurodegenerative Diseases

[8] Sheffield Institute for Translational Neuroscience,Department of Neuroscience

[9] University of Sheffield,Faculté de Médecine

[10] Centre de Référence Maladie Rare (CRMR) SLA Et Les Autres Maladies du Neurone Moteur (FILSLAN),Neurology Department

[11] CHU Bretonneau,Neuroscience Department

[12] Federation des CRMR-SLA Tours-Limoges,Department of Neurology

[13] LITORALS,Clinical Research Centre

[14] INSERM U1253,Medical Affairs

[15] “iBrain,undefined

[16] ” Université François-Rabelais de Tours,undefined

[17] University Hospitals Leuven,undefined

[18] KU Leuven,undefined

[19] UMC Utrecht Brain Center,undefined

[20] University Medical Centre Utrecht,undefined

[21] Academic Unit of Neurology,undefined

[22] Trinity Biomedical Sciences Institute,undefined

[23] Beaumont Hospital,undefined

[24] Bruschettini S.R.L,undefined

[25] Motor Neurone Disease Association,undefined

来源：

Trials | / 24卷

关键词：

Statistical analysis plan; Randomized; Double-blind; Clinical trial; Phase III; Amyotrophic lateral sclerosis; Bile acids;

D O I：

暂无

中图分类号：

学科分类号：

摘要：

引用

共 144 条

[1] Chio A(2013)Global epidemiology of amyotrophic lateral sclerosis: a systematic review of the published literature Neuroepidemiology 41 118-130
[2] Logroscino G(2013)Amyotrophic lateral sclerosis/motor neuron disease deaths in the United States, 1999–2009 Amyotroph Lateral Scler Frontotemporal Degener 14 346-352
[3] Traynor BJ(2019)Riluzole and edaravone: a tale of two amyotrophic lateral sclerosis drugs Med Res Rev 39 733-748
[4] Collins J(2022)Review of disease-modifying drug trials in amyotrophic lateral sclerosis J Neurol Neurosurg Psychiatry 93 521-529
[5] Simeone JC(2016)Tauroursodeoxycholic acid in the treatment of patients with amyotrophic lateral sclerosis Eur J Neurol 23 45-52
[6] Goldstein LA(2022)Tauroursodeoxycholic acid: a potential therapeutic tool in neurodegenerative diseases Transl Neurodegener 11 33-2343
[7] Mehal JM(2017)Guidelines for the Content of Statistical Analysis Plans in Clinical Trials JAMA 318 2337-497
[8] Holman RC(2022)Tauroursodeoxycholic acid in patients with amyotrophic lateral sclerosis: the TUDCA-ALS trial protocol Front Neurol 27 1009113-302
[9] Schonberger LB(2016)Clinical and demographic correlates of medication and visit adherence in a large randomized controlled trial BMC Health Serv Res 16 236-341
[10] Sejvar JJ(2005)Adherence to medication N Engl J Med 353 487-2716

← 1 2 3 4 5 6 7 8 9 10 →