351
Views
59
CrossRef citations to date
0
Altmetric
ORIGINAL ARTICLE

A novel, efficient, randomized selection trial comparing combinations of drug therapy for ALS

, , , , , , , , , , , , , , , , , , , , , , , , , , , , & show all
Pages 212-222 | Received 12 Mar 2008, Published online: 10 Jul 2009

References

  • Rowland LP, Shneider NA. Amyotrophic lateral sclerosis. N Engl J Med. 2001; 344: 1688–700
  • Menzies FM, Ince PG, Shaw PF. Mitochondrial involvement in amyotrophic lateral sclerosis. Neurochemistry International. 2002; 40: 543–51
  • Guegan C, Vila M, Rosoklija G, Hays AP, Przedborski S. Recruitment of the mitochondrial-dependent apoptotic pathway in amyotrophic lateral sclerosis. J Neurosci. 2001; 21: 6569–76
  • Rothstein JD, Martin LJ, Kuncl RW. Decreased glutamate transport by the brain and spinal cord in amyotrophic lateral sclerosis. New Engl J Med. 1992; 236: 1464–8
  • Yoshihara T, Ishigaki S, Yamamoto M, Liang Y, Niwa J, Takeuchi H, et al. Differential expression of inflammation- and apoptosis-related genes in spinal cords of a mutant SOD1 transgenic mouse model of familial amyotrophic lateral sclerosis. J Neurochem. 2002; 80: 158–67
  • Hall ED, Oostveen JA, Gurney ME. Relationship of microglial and astrocytic activation to disease onset and progression in a transgenic model of familial ALS. Glia. 1998; 23: 249–56
  • Gurney ME, Pu H, Chiu AY, Dal Canto MC, Polchow CY, Alexander DD, et al. Motor neuron degeneration in mice that express a human Cu/Zn superoxide dismutase mutation. Science. 1994; 264: 1772–5
  • Lacomblez L, Bensimon G, Leigh PN, Guillet P, Meininger V. Dose-ranging study of riluzole in amyotrophic lateral sclerosis. Amyotrophic Lateral Sclerosis/Riluzole Study Group II. Lancet. 1996; 347: 1425–31
  • Zhu S, Stravrovskaya IG, Drozda M, Kim BY, Ona V, Li M, et al. Minocycline inhibits cytochrome c release and delays progression of amyotrophic lateral sclerosis in mice. Nature. 2002; 417: 74–8
  • van den Bosch L, Tillkin P, Lemmens G, Robberecht W. Minocycline delays disease onset and mortality in a transgenic model of ALS. Neuroreport. 2002; 13: 1067–70
  • Kriz J, Nguyen M, Julien J. Minocycline slows disease progression in a mouse model of amyotrophic lateral sclerosis. Neurobiol Dis. 2002; 10: 268
  • Klivenyi P, Ferrante RJ, Matthews RT, Bogdanov MB, Klein AM, Andreassen OA, et al. Neuroprotective effects of creatine in a transgenic animal model of amyotrophic lateral sclerosis. Nature Med. 1999; 5: 347–50
  • Drachman DB, Frank K, Dykes-Hoberg M, Teismann P, Almer G, Przedborski S, et al. Cyclooxygenase 2 inhibition protects motor neurons and prolongs survival in a transgenic mouse model of ALS. Ann Neurol. 2002; 52: 771–8
  • Zhang W, Narayanan M, Friedlander RM. Additive neuroprotective effects of minocycline with creatine in a mouse model of ALS. Ann Neurol. 2003; 53: 267–70
  • Klivenyi P, Kiaei M, Gardian G, Calingasan NY, Beal MF. Additive neuroprotective effects of creatine and cyclooxygenase 2 inhibitors in a transgenic mouse model of amyotrophic lateral sclerosis. Journal of Neurochemistry. 2004; 88: 576–82
  • Cheung YK, Gordon PH, Levin B. Selecting promising ALS therapies in clinical trials. Neurology. 2006; 67: 1748–51
  • Brooks BR, Miller RG, Swash M, Munsat TL, for the 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;1:557–60.
  • Florence JM, Moore D, Spitalny GM, Miller RG, Gordon PH. Performance of in-person vs. phone ALSFRS-R in a randomized, controlled phase III clinical trial of minocycline in ALS. Amyotroph Lateral Scler Other Motor Neuron Disord. 2006; 7(Suppl 1)116
  • 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
  • Gordon PH, Cheung YK. Progression rate of ALSFRS-R at time of diagnosis predicts survival time in ALS. Neurology. 2006; 67: 1314–5
  • Saivin S, Hovin G. Clinical pharmacokinetics of doxycycline and minocycline. Clin Pharmacokinet. 1988; 15: 355–66
  • Jhee SS, Frackiewicz EJ, Tolbert D. A pharmacokinetic, pharmacodynamic, and safety study of celecoxib in subjects with probable Alzheimer's disease. Clinical research and regulatory affairs. Marcel Dekker. 2004; 21: 49–66
  • The ALS CNTF Treatment Study (ACTS) Phase I-II Study Group. The amyotrophic lateral sclerosis functional rating scale. Assessment of activities of daily living in patients with amyotrophic lateral sclerosis. Arch Neurol. 1996;53:141–7.
  • Cedarbaum JM, Stambler N. Performance of the amyotrophic lateral sclerosis functional rating scale (ALSFRS) in multicenter clinical trials. J Neurol Sci. 1997; 152(Suppl 1)S1–9
  • 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 II/III). J Neurol Sci. 1999; 169: 13–21
  • Miller RG, Moore D, Barohn RJ, Gelinas DF, Dronsky V, Mendoza M, et al. Phase II/III randomized trial of gabapentin in patients with amyotrophic lateral sclerosis. Neurology. 2001; 56: 843–8
  • Scelsa SN, MacGowan DJ, Mitsumoto H, Imperato T, LeValley AJ, Liu MH, et al. A pilot, double-blind, placebo-controlled trial of indinavir in patients with ALS. Neurology. 2005; 64: 1298–300
  • Gordon PH, Moore DH, Miller RG, Florence JM, Verheijde JL, Doorish C, et al. Efficacy of minocycline in patients with amyotrophic lateral sclerosis: a phase III randomized trial. Lancet Neurol. 2007; 6: 1045–53
  • A Controlled trial of recombinant methionyl human BDNF in ALS: The BDNF Study Group (Phase III). Neurology. 1999;52:1427–33.
  • Robbins RA, Simmons Z, Bremer BA, Walsh SM, Fischer S. Quality of life in ALS is maintained as physical function declines. Neurology. 2001; 56: 442–4
  • Montes J, Cheng B, Diamond B, Doorish C, Mitsumoto H, Gordon PH. The Timed Up and Go test: predicting falls in ALS. Amyotroph Lateral Scler. 2007; 8: 292–5
  • Levin B. The utility of futility. Stroke. 2005; 36: 2331–2
  • Cudkowicz ME, Shefner JM, Schoenfeld DA, Brown RH, Jr, Johnson H, Qureshi M, et al. A randomized, placebo-controlled trial of topiramate in amyotrophic lateral sclerosis. Neurology. 2003; 61: 456–64
  • Miller R, Bradley W, Cudkowicz, Hubble J, Meininger V, Mitsumoto H, et al. Phase II/III randomized trial of TCH346 in patients with ALS. Neurology. 2007; 69: 776–84
  • Meininger V, Bensimon G, Bradley WR, Brooks B, Douillet P, Eisen AA, et al. Efficacy and safety of xaliproden in amyotrophic lateral sclerosis: results of two phase III trials. Amyotroph Lateral Scler Other Motor Neuron Disord. 2004; 5: 107–17
  • Ellis AC, Rosenfeld J. The role of creatine in the management of amyotrophic lateral sclerosis and other neurodegenerative disorders. CNS Drugs. 2004; 18: 967–80
  • Nakayama M, Uchimura K, Zhu R, Nagayama T, Rose ME, Stetler RA, et al. Cyclooxygenase-2 inhibition prevents delayed death of CA1 hippocampal neurons following global ischemia. Proc Natl Acad Sci U S A. 1998; 95: 10954–9
  • Kaufmann P, Levy G, Thompson JL, Delbene ML, Battista V, Gordon PH, et al. The ALSFRS-R predicts survival time in an ALS clinic population. Neurology. 2005; 64: 38–43
  • Gordon PH, Cheng B, Montes J, Doorish C, Albert SM, Mitsumoto H. Outcome measures for early phase clinical trials. Amyotroph Lateral Scler. 2007; 8: 270–3
  • Groeneveld GJ, Veldink JH, van der Tweel I, Kalmijn S, Beijer C, de Visser M, et al. A randomized sequential trial of creatine in amyotrophic lateral sclerosis. Ann Neurol. 2003; 53: 437–45
  • Shefner JM, Cudkowicz ME, Schoenfeld D, Conrad T, Taft J, Chilton M, et al. A clinical trial of creatine in ALS. Neurology. 2004; 63: 1656–61
  • Cudkowicz ME, Shefner JM, Schoenfeld DA, Zhang H, Andreasson KI, Rothstein JD, Drachman DB. Trial of celecoxib in amyotrophic lateral sclerosis. Ann Neurol. 2006; 60: 22–31
  • Hersch SM, Gevorkian S, Marder K, Moskowitz C, Feigin A, Cox M, et al. Creatine in Huntington's disease is safe, tolerable, bioavailable in brain and reduces serum 8OH2'dG. Neurology. 2006; 66: 250–2

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.