573
Views
72
CrossRef citations to date
0
Altmetric
Original Article

Glatiramer acetate has no impact on disease progression in ALS at 40 mg/day: A double- blind, randomized, multicentre, placebo-controlled trial

, , , , &
Pages 378-383 | Received 27 Nov 2008, Published online: 18 Nov 2009

References

  • Bruijn LI, Miller TM, Cleveland DW. Unravelling the mechanisms involved in motor neuron degeneration in ALS. Annu Rev Neurosci. 2004; 27: 723–49
  • Boillée S, van de Velde C, Cleveland DW. ALS: a disease of motor neurons and their non-neuronal neighbours. Neuron. 2006; 52: 39–59
  • Henkel JS, Beers DR, Siklos L, Appel SH. The chemokine MCP-1 and the dendritic and myeloid cells it attracts are increased in the mSOD1 mouse model of ALS. Mol Cell Neurosci. 2006; 31: 427–37
  • Liu B, Hong JS. Role of microglia in inflammation-mediated neurodegenerative diseases: mechanisms and strategies for therapeutic intervention. J Pharmacol Exp Therapeutic. 2003; 304: 1–7
  • Kipnis J, Schwartz M. Controlled autoimmunity in CNS maintenance and repair: naturally occurring CD4+ CD25+ regulatory T-cells at the crossroads of health and disease. Neuromolecular Med. 2005; 7: 197–206
  • Holmøy T. T-cells in amyotrophic lateral sclerosis. Eur J Neurol. 2008; 15: 360–6
  • Farina C, Weber MS, Meinl E, Wekerle H, Hohlfeld R. Glatiramer acetate in multiple sclerosis: update on potential mechanisms of action. Lancet Neurol. 2005; 4: 567–75
  • Weber MS, Starck M, Wagenpfeil S, Meinl E, Hohlfeld R, Farina C. Multiple sclerosis: glatiramer acetate inhibits monocyte reactivity in vitro and in vivo. Brain. 2004; 127: 1370–8
  • Hussien Y, Sanna A, Soderstrom M, Link H, Huang YM. Glatiramer acetate and IFN-β act on dendritic cells in multiple sclerosis. J Neuroimmunol. 2001; 121: 102–10
  • Arnon R, Aharoni R. Neurogenesis and neuroprotection in the CNS: fundamental elements in the effect of glatiramer acetate on treatment of autoimmune neurological disorders. Mol Neurobiol. 2007; 36: 245–53
  • Chen M, Valenzuela RM, Dhib-Jalbut S. Glatiramer acetate-reactive T-cells produce brain derived neurotrophic factor. J Neurol Sci. 2003; 215: 37–44
  • Kerschensteiner M, Stadelmann C, Dechant G, Wekerle H, Hohlfeld R. Neurotrophic cross-talk between the nervous and immune systems: implications for neurological diseases. Ann Neurol. 2003; 53: 292–304
  • Angelov DN, Waibel S, Guntinas-Lichius O, Lenzen M, Neiss WF, Tomov TL, et al. Therapeutic vaccine for acute and chronic motor neuron diseases: implications for amyotrophic lateral sclerosis. Proc Natl Acad Sci U S A. 2003; 100: 4790–5
  • Habisch HJ, Schwalenstöcker B, Danzeisen R, Neuhaus O, Hartung HP, Ludolph A. Limited effects of glatiramer acetate in the high-copy number hSOD1-G93A mouse model of ALS. Exp Neurol. 2007; 206: 288–95
  • Haenggeli C, Julien JP, Mosley RL, Perez N, Dhar A, Gendelman HE, Rothstein JD. Therapeutic immunization with a glatiramer acetate derivative does not alter survival in G93A and G37R-SOD1 mouse models of familial ALS. Neurobiol Dis. 2007; 26: 146–52
  • Ludolph AC, Bendotti C, Blaugrund E, Hengerer B, Löffler JP, Martin J, et al. Guidelines for the preclinical in vivo evaluation of pharmacologically active drugs for ALS/MND: report on the 142nd ENMC International Workshop. Amyotroph Lateral Scler. 2007; 8: 217–23
  • Gordon PH, Doorish C, Montes J, Mosley RL, Diamond B, Macarthur RB, et al. Randomized, controlled phase II trial of glatiramer acetate in ALS. Neurology. 2006; 66: 1117–9
  • CPMP. Working Party on Efficacy of Medicinal Products. Guideline for Good Clinical Practice. CPMP/ICH/135/95. EMEA. http://www.emea.eu.int/pdfs/human/ich/013595en.pdf.
  • Slowing the progression of neurodegenerative diseases: Medicinal products (MP) clinical development. London, 2 October 2006. Doc. Ref. EMEA/512562/2006.
  • Brooks, B. El Escorial World Federation of Neurology criteria for the diagnosis of amyotrophic lateral sclerosis. Subcommittee on Motor Neuron Diseases/Amyotrophic Lateral Sclerosis of the World Federation of Neurology Research Group on Neuromuscular Diseases and the El Escorial ‘Clinical limits of amyotrophic lateral sclerosis’. J Neurol Sci. 1994;124(Suppl):96–107.
  • Cedarbaum JM, Stambler N, Malta E, et al. The ALSFRSR: 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
  • Cox DR. Regression models and life-tables. J R Stat Soc [B] 1972; 34: 187–220
  • Lanka V, Cudkowicz M. Therapy development for ALS: lessons learned and path forward. Amyotroph Lateral Scler. 2008; 9: 131–40
  • Swash M. Learning from failed trials in ALS. Lancet Neurol. 2007; 6: 1034–5
  • Leigh PN, Meininger V, Bensimon G, Cudkowicz M, Robberecht W. Minocycline for patients with ALS. Lancet Neurol. 2008; 7: 119–20
  • Miller R, Bradley W, Cudkowicz M, Hubble J, Meininger V, Mitsumoto H, et al. Phase II/III randomized trial of TCH346 in patients with ALS. Neurology. 2007; 69: 776–84
  • Barbeito LH, Pehar M, Cassina P, Vargas MR, Peluffo H, Viera L, Estévez AG. A role for astrocytes in motor neuron loss in amyotrophic lateral sclerosis. Brain Res Brain Res Rev. 2004; 47: 263–74
  • Beckman JS, Boillee S, Yamanaka K, Lobsiger CS, Copeland NG, Jenkins NA, et al. Onset and progression in inherited ALS determined by motor neurons and microglia. Science. 2006; 312: 1389–92
  • Zhang R, Gascon R, Miller RG, Gelinas DF, Mass J, Hadlock K, et al. Evidence for systemic immune system alterations in sporadic amyotrophic lateral sclerosis (SALS). J Neuroimmunol. 2005; 159: 215–24
  • Zhao W, Xiao Q, Henkel JS, Beers DR, Simpson EP, Yen AA, et al. Activated microglia in ALS: a double-edged sword. Amyotroph Lateral Scler. 2005; 6(Suppl 1)27–9
  • Schoenfeld DA, Cudkowicz M. Design of phase II ALS clinical trials. Amyotroph Lateral Scler. 2008; 9: 16–23

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.