Randomized controlled phase II trial of glatiramer acetate in ALS

被引:42
作者
Gordon, PH
Doorish, C
Montes, J
Mosely, RL
Diamond, B
MacArthur, RB
Weimer, LH
Kaufmann, P
Hays, AP
Rowland, LP
Gendelman, HE
Przedborski, S
Mitsumoto, H
机构
[1] Columbia Univ, Dept Neurol, Gen Clin Res Ctr, New York, NY 10027 USA
[2] Columbia Univ, Dept Pharmacol, Gen Clin Res Ctr, New York, NY 10027 USA
[3] Columbia Univ, Dept Pathol, Gen Clin Res Ctr, New York, NY 10027 USA
[4] Columbia Univ, Dept Biostat, Gen Clin Res Ctr, New York, NY 10027 USA
[5] Univ Nebraska, Med Ctr, Dept Pharmacol & Expt Neurosci, Ctr Neurovirol & Neurodegenerat Disorders, Omaha, NE USA
关键词
D O I
10.1212/01.wnl.0000204235.81272.e2
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
The authors conducted a randomized controlled trial to test the safety and immunology of glatiramer acetate in ALS. Twenty treated patients were randomly assigned to daily or biweekly injections. Ten control patients were selected from another trial and followed up concurrently. Injection reactions were the only common adverse event (p = 0.01). Treated patients showed enhanced lymphocyte proliferation (p = 0.02). The safety profile and immune effects support conducting larger trials of dose selection and efficacy.
引用
收藏
页码:1117 / 1119
页数:3
相关论文
共 10 条
[1]   Therapeutic vaccine for acute and chronic motor neuron diseases: Implications for amyotrophic lateral sclerosis [J].
Angelov, DN ;
Waibel, S ;
Guntinas-Lichius, O ;
Lenzen, M ;
Neiss, WF ;
Tomov, TL ;
Yoles, E ;
Kipnis, J ;
Schori, H ;
Reuter, A ;
Ludolph, A ;
Schwartz, M .
PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA, 2003, 100 (08) :4790-4795
[2]   Therapeutic immunization protects dopaminergic neurons in a mouse model of Parkinson's disease [J].
Benner, EJ ;
Mosley, RL ;
Destache, CJ ;
Lewis, TB ;
Jackson-Lewis, V ;
Gorantla, S ;
Nemachek, C ;
Green, SR ;
Przedborski, S ;
Gendelman, HE .
PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA, 2004, 101 (25) :9435-9440
[3]   Immunological assay for assessing the efficacy of glatiramer acetate (Copaxone) in multiple sclerosis - A pilot study [J].
Farina, C ;
Wagenpfeil, S ;
Hohlfeld, R .
JOURNAL OF NEUROLOGY, 2002, 249 (11) :1587-1592
[4]   Disease modifying therapies in multiple sclerosis - Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines [J].
Goodin, DS ;
Frohman, EM ;
Garmany, GP ;
Halper, J ;
Likosky, WH ;
Lublin, FD ;
Silberberg, DH ;
Stuart, WH ;
van den Noort, S .
NEUROLOGY, 2002, 58 (02) :169-178
[5]  
HAENGGELI D, 2005, ANN NEUROL, V58, pS28
[6]  
HIRANO A, 1991, ADV NEUROL, V56, P91
[7]   COPOLYMER-1 REDUCES RELAPSE RATE AND IMPROVES DISABILITY IN RELAPSING-REMITTING MULTIPLE-SCLEROSIS - RESULTS OF A PHASE-III MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL [J].
JOHNSON, KP ;
BROOKS, BR ;
COHEN, JA ;
FORD, CC ;
GOLDSTEIN, J ;
LISAK, RP ;
MYERS, LW ;
PANITCH, HS ;
ROSE, JW ;
SCHIFFER, RB ;
VOLLMER, T ;
WEINER, LP ;
WOLINSKY, JS ;
BIRD, SJ ;
CONSTANTINESCU, C ;
KOLSON, DL ;
GONZALEZSCARANO, F ;
BRENNAN, D ;
PFOHL, D ;
MANDLER, RN ;
ROSENBERG, GA ;
JEFFREY, C ;
BARGER, GR ;
GANDHI, B ;
MOORE, PM ;
ROGERS, LR ;
LISAK, D ;
SMITH, L ;
ELLISON, GW ;
BAUMHEFNER, RW ;
CRAIG, SL ;
JALBUT, SS ;
KATZ, E ;
CONWAY, KL ;
BURNS, JB ;
SHIBA, C ;
GIANG, DW ;
PETRIE, MD ;
GUARNACCIA, JB ;
ANDERSON, S ;
MCKEON, A ;
MCCARTHY, M ;
THOMAS, AB ;
VRIESENDORP, FJ ;
AUSTIN, SG ;
LINDSEY, JW ;
DIMACHKIE, M ;
CERRETA, E ;
KACHUCK, N ;
MCCARTHY, KA .
NEUROLOGY, 1995, 45 (07) :1268-1276
[8]   OXIDATIVE DAMAGE TO PROTEIN IN SPORADIC MOTOR-NEURON DISEASE SPINAL-CORD [J].
SHAW, PJ ;
INCE, PG ;
FALKOUS, G ;
MANTLE, D .
ANNALS OF NEUROLOGY, 1995, 38 (04) :691-695
[9]   Glatiramer acetate (GA) induces IL-13/Il-5 secretion in naive T cells [J].
Wiesemann, E ;
Klatt, J ;
Sönmez, D ;
Blasczyk, R ;
Heidenreich, F ;
Windhagen, A .
JOURNAL OF NEUROIMMUNOLOGY, 2001, 119 (01) :137-144
[10]   Glatiramer acetate-specific T-helper 1-and 2-type cell lines produce BDNF:: implications for multiple sclerosis therapy [J].
Ziemssen, T ;
Kümpfel, T ;
Klinkert, WEF ;
Neuhaus, O ;
Hohlfeld, R .
BRAIN, 2002, 125 :2381-2391