Clinical trial NCT00877604 - References

Amyotrophic Lateral Sclerosis — Efficacy and Tolerability of Tauroursodeoxycholic Acid in Amyotrophic Lateral Sclerosis

Citation(s)

•   Al-Chalabi A, Andersen PM, Nilsson P, Chioza B, Andersson JL, Russ C, Shaw CE, Powell JF, Leigh PN
  Deletions of the heavy neurofilament subunit tail in amyotrophic lateral sclerosis. Hum Mol Genet. 1999 Feb;8(2):157-64.
•   Bensimon G, Lacomblez L, Meininger V
  A controlled trial of riluzole in amyotrophic lateral sclerosis. ALS/Riluzole Study Group. N Engl J Med. 1994 Mar 3;330(9):585-91.
•   Benz C, Angermüller S, Otto G, Sauer P, Stremmel W, Stiehl A
  Effect of tauroursodeoxycholic acid on bile acid-induced apoptosis in primary human hepatocytes. Eur J Clin Invest. 2000 Mar;30(3):203-9.
•   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 Dec;1(5):293-9. Review.
•   Castro RE, Solá S, Ramalho RM, Steer CJ, Rodrigues CM
  The bile acid tauroursodeoxycholic acid modulates phosphorylation and translocation of bad via phosphatidylinositol 3-kinase in glutamate-induced apoptosis of rat cortical neurons. J Pharmacol Exp Ther. 2004 Nov;311(2):845-52. Epub 2004 Jun 9.
•   Cedarbaum JM, Stambler N, Malta E, Fuller C, Hilt D, Thurmond B, Nakanishi A
  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 Oct 31;169(1-2):13-21.
•   Chaudhuri KR, Crump S, al-Sarraj S, Anderson V, Cavanagh J, Leigh PN
  The validation of El Escorial criteria for the diagnosis of amyotrophic lateral sclerosis: a clinicopathological study. J Neurol Sci. 1995 May;129 Suppl:11-2.
•   Cleveland DW, Rothstein JD
  From Charcot to Lou Gehrig: deciphering selective motor neuron death in ALS. Nat Rev Neurosci. 2001 Nov;2(11):806-19. Review.
•   Emery AE, Holloway S
  Familial motor neuron diseases. Adv Neurol. 1982;36:139-47.
•   Friedlander RM
  Apoptosis and caspases in neurodegenerative diseases. N Engl J Med. 2003 Apr 3;348(14):1365-75. Review.
•   Heath PR, Shaw PJ
  Update on the glutamatergic neurotransmitter system and the role of excitotoxicity in amyotrophic lateral sclerosis. Muscle Nerve. 2002 Oct;26(4):438-58. Review.
•   Ince PG, Tomkins J, Slade JY, Thatcher NM, Shaw PJ
  Amyotrophic lateral sclerosis associated with genetic abnormalities in the gene encoding Cu/Zn superoxide dismutase: molecular pathology of five new cases, and comparison with previous reports and 73 sporadic cases of ALS. J Neuropathol Exp Neurol. 1998 Oct;57(10):895-904.
•   Keene CD, Rodrigues CM, Eich T, Chhabra MS, Steer CJ, Low WC
  Tauroursodeoxycholic acid, a bile acid, is neuroprotective in a transgenic animal model of Huntington's disease. Proc Natl Acad Sci U S A. 2002 Aug 6;99(16):10671-6. Epub 2002 Jul 29.
•   Keene CD, Rodrigues CM, Eich T, Linehan-Stieers C, Abt A, Kren BT, Steer CJ, Low WC
  A bile acid protects against motor and cognitive deficits and reduces striatal degeneration in the 3-nitropropionic acid model of Huntington's disease. Exp Neurol. 2001 Oct;171(2):351-60.
•   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 May 25;347(9013):1425-31.
•   Leigh PN, Swash M, Iwasaki Y, Ludolph A, Meininger V, Miller RG, Mitsumoto H, Shaw P, Tashiro K, Van Den Berg L
  Amyotrophic lateral sclerosis: a consensus viewpoint on designing and implementing a clinical trial. Amyotroph Lateral Scler Other Motor Neuron Disord. 2004 Jun;5(2):84-98. Review.
•   Mandrioli J, Faglioni P, Merelli E, Sola P
  The epidemiology of ALS in Modena, Italy. Neurology. 2003 Feb 25;60(4):683-9.
•   Miller RG, Munsat TL, Swash M, Brooks BR
  Consensus guidelines for the design and implementation of clinical trials in ALS. World Federation of Neurology committee on Research. J Neurol Sci. 1999 Oct 31;169(1-2):2-12. Review.
•   Miller SD, Greene CM, McLean C, Lawless MW, Taggart CC, O'Neill SJ, McElvaney NG
  Tauroursodeoxycholic acid inhibits apoptosis induced by Z alpha-1 antitrypsin via inhibition of Bad. Hepatology. 2007 Aug;46(2):496-503.
•   Moore DH 2nd, Miller RG
  Improving efficiency of ALS clinical trials using lead-in designs. Amyotroph Lateral Scler Other Motor Neuron Disord. 2004 Sep;5 Suppl 1:57-60.
•   Orrell RW, Lane RJ, Ross M
  Antioxidant treatment for amyotrophic lateral sclerosis / motor neuron disease. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD002829. Review. Update in: Cochrane Database Syst Rev. 2007;(1):CD002829.
•   Puls I, Jonnakuty C, LaMonte BH, Holzbaur EL, Tokito M, Mann E, Floeter MK, Bidus K, Drayna D, Oh SJ, Brown RH Jr, Ludlow CL, Fischbeck KH
  Mutant dynactin in motor neuron disease. Nat Genet. 2003 Apr;33(4):455-6. Epub 2003 Mar 10.
•   Ramalho RM, Borralho PM, Castro RE, Solá S, Steer CJ, Rodrigues CM
  Tauroursodeoxycholic acid modulates p53-mediated apoptosis in Alzheimer's disease mutant neuroblastoma cells. J Neurochem. 2006 Sep;98(5):1610-8.
•   Ramalho RM, Ribeiro PS, Solá S, Castro RE, Steer CJ, Rodrigues CM
  Inhibition of the E2F-1/p53/Bax pathway by tauroursodeoxycholic acid in amyloid beta-peptide-induced apoptosis of PC12 cells. J Neurochem. 2004 Aug;90(3):567-75.
•   Rizzardini M, Lupi M, Bernasconi S, Mangolini A, Cantoni L
  Mitochondrial dysfunction and death in motor neurons exposed to the glutathione-depleting agent ethacrynic acid. J Neurol Sci. 2003 Mar 15;207(1-2):51-8.
•   Robertson J, Kriz J, Nguyen MD, Julien JP
  Pathways to motor neuron degeneration in transgenic mouse models. Biochimie. 2002 Nov;84(11):1151-60. Review.
•   Rodrigues CM, Sola S, Nan Z, Castro RE, Ribeiro PS, Low WC, Steer CJ
  Tauroursodeoxycholic acid reduces apoptosis and protects against neurological injury after acute hemorrhagic stroke in rats. Proc Natl Acad Sci U S A. 2003 May 13;100(10):6087-92. Epub 2003 Apr 29.
•   Rodrigues CM, Solá S, Sharpe JC, Moura JJ, Steer CJ
  Tauroursodeoxycholic acid prevents Bax-induced membrane perturbation and cytochrome C release in isolated mitochondria. Biochemistry. 2003 Mar 18;42(10):3070-80.
•   Rosen DR
  Mutations in Cu/Zn superoxide dismutase gene are associated with familial amyotrophic lateral sclerosis. Nature. 1993 Jul 22;364(6435):362.
•   Rowland LP, Shneider NA
  Amyotrophic lateral sclerosis. N Engl J Med. 2001 May 31;344(22):1688-700. Review.
•   Rudolph G, Kloeters-Plachky P, Sauer P, Stiehl A
  Intestinal absorption and biliary secretion of ursodeoxycholic acid and its taurine conjugate. Eur J Clin Invest. 2002 Aug;32(8):575-80.
•   Sathasivam S, Ince PG, Shaw PJ
  Apoptosis in amyotrophic lateral sclerosis: a review of the evidence. Neuropathol Appl Neurobiol. 2001 Aug;27(4):257-74. Review.
•   Schoemaker MH, Conde de la Rosa L, Buist-Homan M, Vrenken TE, Havinga R, Poelstra K, Haisma HJ, Jansen PL, Moshage H
  Tauroursodeoxycholic acid protects rat hepatocytes from bile acid-induced apoptosis via activation of survival pathways. Hepatology. 2004 Jun;39(6):1563-73.
•   Shaw CE, al-Chalabi A, Leigh N
  Progress in the pathogenesis of amyotrophic lateral sclerosis. Curr Neurol Neurosci Rep. 2001 Jan;1(1):69-76. Review.
•   Shaw CE, Enayat ZE, Chioza BA, Al-Chalabi A, Radunovic A, Powell JF, Leigh PN
  Mutations in all five exons of SOD-1 may cause ALS. Ann Neurol. 1998 Mar;43(3):390-4.
•   Solá S, Castro RE, Laires PA, Steer CJ, Rodrigues CM
  Tauroursodeoxycholic acid prevents amyloid-beta peptide-induced neuronal death via a phosphatidylinositol 3-kinase-dependent signaling pathway. Mol Med. 2003 Sep-Dec;9(9-12):226-34.
•   Turner MR, Bakker M, Sham P, Shaw CE, Leigh PN, Al-Chalabi A
  Prognostic modelling of therapeutic interventions in amyotrophic lateral sclerosis. Amyotroph Lateral Scler Other Motor Neuron Disord. 2002 Mar;3(1):15-21.
•   Ved R, Saha S, Westlund B, Perier C, Burnam L, Sluder A, Hoener M, Rodrigues CM, Alfonso A, Steer C, Liu L, Przedborski S, Wolozin B
  Similar patterns of mitochondrial vulnerability and rescue induced by genetic modification of alpha-synuclein, parkin, and DJ-1 in Caenorhabditis elegans. J Biol Chem. 2005 Dec 30;280(52):42655-68. Epub 2005 Oct 19.
•   Waldmeier PC
  Prospects for antiapoptotic drug therapy of neurodegenerative diseases. Prog Neuropsychopharmacol Biol Psychiatry. 2003 Apr;27(2):303-21. Review.
•   Worms PM
  The epidemiology of motor neuron diseases: a review of recent studies. J Neurol Sci. 2001 Oct 15;191(1-2):3-9. Review.
•   Yang Y, Hentati A, Deng HX, Dabbagh O, Sasaki T, Hirano M, Hung WY, Ouahchi K, Yan J, Azim AC, Cole N, Gascon G, Yagmour A, Ben-Hamida M, Pericak-Vance M, Hentati F, Siddique T
  The gene encoding alsin, a protein with three guanine-nucleotide exchange factor domains, is mutated in a form of recessive amyotrophic lateral sclerosis. Nat Genet. 2001 Oct;29(2):160-5.

A Randomized, Double-blind Multicenter Pilot Study vs. Placebo for the Evaluation of Efficacy and Tolerability of Tauroursodeoxycholic Acid Administered by Oral Route as Add on Treatment in Patients Affected by Amyotrophic Lateral Sclerosis

Details for clinical trial NCT00877604