Advanced search
Publication Cover
Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration Volume 21, 2020 - Issue 7-8
Submit an article Journal homepage
2,308
Views
4
CrossRef citations to date
0
Altmetric
Clinical Trial

A placebo-controlled trial to investigate the safety and efficacy of Penicillin G/Hydrocortisone in patients with ALS (PHALS trial)

Michael A. Van Es1 Department of Neurology, UMC Utrecht Brain Center, University Medical Centre Utrecht, Utrecht, the NetherlandsView further author information
,
Ruben P.A. Van Eijk1 Department of Neurology, UMC Utrecht Brain Center, University Medical Centre Utrecht, Utrecht, the Netherlands;2 Biostatistics & Research Support, Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, the NetherlandsView further author information
,
Tommy M. Bunte1 Department of Neurology, UMC Utrecht Brain Center, University Medical Centre Utrecht, Utrecht, the NetherlandsView further author information
&
Leonard H. Van Den Berg1 Department of Neurology, UMC Utrecht Brain Center, University Medical Centre Utrecht, Utrecht, the NetherlandsCorrespondence[email protected]
View further author information
Pages 584-592 | Received 20 Apr 2020, Accepted 21 Jun 2020, Published online: 06 Jul 2020

References

  • Tuk B, Jousma H, Gaillard PJ. Treatment with penicillin G and hydrocortisone reduces ALS-associated symptoms: a case series of three patients. F1000Res. 2017;6:410.
  • Tuk B. Syphilis may be a confounding factor, not a causative agent, in syphilitic ALS. F1000Res. 2016;5:1904.
  • Tuk B. Overstimulation of the inhibitory nervous system plays a role in the pathogenesis of neuromuscular and neurological diseases: a novel hypothesis. F1000Res. 2016;5:1435.
  • Bedlack R, ALSUntangled Group. ALSUntangled 46: penicillin G/hydrocortisone. Amyotroph Lateral Scler Frontotemporal Degener. 2019;20:126–31.
  • van Es MA, Hardiman O, Chio A, Al-Chalabi A, Pasterkamp RJ, Veldink JH, et al. Amyotrophic lateral sclerosis. Lancet. 2017;390:2084–98.
  • Hoye ML, Regan MR, Jensen LA, Lake AM, Reddy LV, Vidensky S, et al. Motor neuron-derived microRNAs cause astrocyte dysfunction in amyotrophic lateral sclerosis. Brain. 2018;141:2561–75.
  • Cudkowicz ME, Titus S, Kearney M, Yu H, Sherman A, Schoenfeld D, et al. Safety and efficacy of ceftriaxone for amyotrophic lateral sclerosis: a multi-stage, randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2014;13:1083–91.
  • Brooks BR, Miller RG, Swash M, Munsat TL, World Federation of Neurology Research Group on Motor Neuron Diseases. El Escorial revisited: revised criteria for the diagnosis of amyotrophic lateral sclerosis. Amyotroph Lateral Scler Other Motor Neuron Disord. 2000;1:293–9.
  • Cedarbaum JM, Stambler N, Malta E, Fuller C, Hilt D, Thurmond B, et al. The ALSFRS-R: a revised ALS functional rating scale that incorporates assessments of respiratory function. BDNF ALS Study Group (Phase III). J Neurol Sci. 1999;169:13–21.
  • van Eijk RPA, Westeneng HJ, Nikolakopoulos S, Verhagen IE, van Es MA, Eijkemans MJC, et al. Refining eligibility criteria for amyotrophic lateral sclerosis clinical trials. Neurology 2019;92:e451–60.
  • Westeneng HJ, Debray TPA, Visser AE, van Eijk RPA, Rooney JPK, Calvo A, et al. Prognosis for patients with amyotrophic lateral sclerosis: development and validation of a personalised prediction model. Lancet Neurol. 2018;17:423–33.
  • van Eijk RP, Eijkemans MJ, Rizopoulos D, van den Berg LH, Nikolakopoulos S. Comparing methods to combine functional loss and mortality in clinical trials for amyotrophic lateral sclerosis. Clin Epidemiol. 2018;10:333–41.
  • Atassi N, Berry J, Shui A, Zach N, Sherman A, Sinani E, et al. The PRO-ACT database: design, initial analyses, and predictive features. Neurology 2014;83:1719–25.
  • Kimura F, Fujimura C, Ishida S, Nakajima H, Furutama D, Uehara H, et al. Progression rate of ALSFRS-R at time of diagnosis predicts survival time in ALS. Neurology 2006;66:265–7.
  • Chio A, Logroscino G, Hardiman O, Swingler R, Mitchell D, Beghi E, et al. Prognostic factors in ALS: a critical review. Amyotroph Lateral Scler. 2009;10:310–23.
  • Bedlack RS, Wicks P, Vaughan T, Opie A, Blum R, Dios A, et al. Lunasin does not slow ALS progression: results of an open-label, single-center, hybrid-virtual 12-month trial. Amyotroph Lateral Scler Frontotemporal Degener. 2019;20:285–93.
  • Writing G, Edaravone A. Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurol 2017;16:505–12.
  • Turnbull J. Is edaravone harmful? (A placebo is not a control). Amyotroph Lateral Scler Frontotemporal Degener. 2018;19:477–82.
  • Turnbull J. Author response to a Letter to the Editor entitled: edaravone administration in pivotal clinical study 19 (Authors: Genge, Angela; Brooks, Benjamin). Amyotroph Lateral Scler Frontotemporal Degener. 2019;20:300–2.
  • Smith LG. Improvement of patient with amyotrophic lateral sclerosis given ceftriaxone. Lancet. 1992;339:1417.
  • Smith LG. Failure of ceftriaxone for amyotrophic lateral sclerosis. Lancet. 1992;340:379.
  • Norris FH. Ceftriaxone in amyotrophic lateral sclerosis. Arch Neurol. 1994;51:447.
  • Rothstein JD, Patel S, Regan MR, Haenggeli C, Huang YH, Bergles DE, et al. Beta-lactam antibiotics offer neuroprotection by increasing glutamate transporter expression. Nature 2005;433:73–7.

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.