Abstract
My task is to describe the evolution over the past 20 years of clinical trial designs in multiple sclerosis to their current state; to list major milestones as I see them; and to point out past, present, and future difficulties. From other chapters of the book, I have selected examples of milestones reached, and of problems solved and to be solved by future clinical trialists.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
References
Bornstein MB, Miller A, Slagle S et al. (1987) A pilot trial of Cop 1 in exacerbating-remitting multiple sclerosis. N Engl J Med 317: 408–414
British and Dutch Multiple Sclerosis Azathioprine Trial Group (1988) Double-masked trial of azathioprine in multiple sclerosis. Lancet 2: 179–183
Broman T (1970) Management of patients with multiple sclerosis. In: Vinken PJ, Bruyn GW (eds) Multiple sclerosis and other demyelinating diseases. North-Holland Publishing Company, Amsterdam, pp 408–425 (Handbook of clinical neurology, vol 9 )
Brown JR, Beebe GW, Kurtzke JF, Loewenson RB, Silberberg DH, Tourtellotte WW (1979) The design of clinical studies to assess therapeutic efficacy in multiple sclerosis. Neurology 29: 1–23
Detels R, Clark VA, Valdiviezo NL, Visscher BR, Malmgren RM, Dudley JP (1982) Factors associated with a rapid course of multiple sclerosis. Arch Neurol 39: 337–341
Detsky AS (1985) When was a negative clinical trial big enough? How many patients you needed depends on what you found. Arch Intern Med 145: 709–712
DHEW 1974 — US Department of Health, Education, and Welfare (February 11, 1974 ) National Advisory Commission on Multiple Sclerosis, Report and Recommendations. HEW, Public Health Service, National Institutes of Health, Washington DC, Publication # (NIH) 74–534: 36–38
DHEW 1977 — US Department of Health, Education, and Welfare, Food and Drug Administration (September 1977) General considerations for the clinical evaluation of drugs. US Government Printing Office, Washington DC, HEW (FDA) 77–3040: 6–11
DHEW 1979 — US Department of Health, Education, and Welfare. Public Health Service, National Institutes of Health. National Institute of Neurological and Communicative Disorders and Stroke (1979) Report of the panel on inflammatory, demyelinating, and degenerative diseases to the national advisory neurological and communicative disorders and stroke council. Washington DC, NIH Publication No. 79–1916: 24–30
Ellison GW, Myers LW (1980) Immunosuppressive drugs in multiple sclerosis: pro and con. Neurology 30 (7 Pt 2): 28–32
Ellison GW, Myers LW, Mickey MR et al. (1983) Multiple sclerosis: patient accrual problems in a therapeutic trial. Neurology 33 (suppl 2): 71
Ellison GW, Mickey MR, Myers LW (1988) Alternatives to randomized clinical trials. Neurology 38 (7 Suppl 2): 73–75
Ellison GW, Myers LW, Mickey MR et al. (1989) A placebo-controlled, randomized, double-masked, variable dosage, clinical trial of azathioprine with and without methylprednisolone in multiple sclerosis. Neurology 39: 1018–1026
Goodkin DE, Bailly R, Teetzen M, Hertsgaard D (1991) The efficacy of azathioprine in relapsing-remitting multiple sclerosis. Neurology 41: 20–25
Hauser SL, Dawson DM, Lehrich JR et al. (1983) Intensive immunosuppression in progressive multiple sclerosis. A randomized, three-arm study of high-dose intravenous cyclophosphamide, plasma exchange, and ACTH. N Engl J Med 308: 173–180
Herndon RM, Murray TJ (1983) Proceedings of the international conference on therapeutic trials in multiple sclerosis. Arch Neurol 40: 663–710
Hommes OR, Prick JJG, Lamers KJB (1975) Treatment of the chronic progressive form of multiple sclerosis with a combination of cyclophosphamide and prednisone. Clin Neurol Neurosurg 78: 59–72
Hulley SB, Cummings SR (1988) Designing clinical research. Williams and Wilkins, Baltimore IFMSS (International Federation of Multiple Sclerosis Societies) (1982) Therapeutic claims in multiple sclerosis. National Multiple Sclerosis Society, New York
Johnson KP (1983) Systemic interferon therapy for multiple sclerosis. Design of a trial. Arch Neurol 40: 681–682
Johnson MA, Li DKB, Bryant DJ, Payne JA (1984) Magnetic resonance imaging: serial observation in multiple sclerosis. AJNR 5: 495–499
Knobler RL, Panitch HS, Braheny SL et al. (1984) Systemic alpha-interferon therapy of multiple sclerosis. Neurology 34: 1273–1279
Kurtzke JF (1983) Rating neurologic impairment in multiple sclerosis: An expanded disability status scale (EDSS). Neurology 33: 1444–1452
Kurtzke JF (1986) Neuroepidemiology. Part II. Assessment of therapeutic trials. Ann Neurol 19: 311–319
Kurtzke JF (1987) Problems and pitfalls in treatment trials of multiple sclerosis. Neuroepidemiology 6: 17–33
Li D, Mayo J, Fache S, Robertson WD, Paty D, Genton M (1984) Early experience in nuclear magnetic resonance imaging of multiple sclerosis. Ann NY Acad Sci 436: 484–486
McAlpine D, Compston N (1952) Some aspects of the natural history of disseminated sclerosis. Q J Med 21: 135–167
McAlpine D, Compston ND, Lumsden CE (1955) Multiple sclerosis. Livingstone, Edinburgh, p 139
McAlpine D, Lumsden CE, Acheson ED (1972) Multiple sclerosis, a reappraisal. Williams and Wilkins, Baltimore, pp 197–223
Miller AE, Bornstein M, Slagle S et al. (1989) Clinical trial of Copl in chronic-progressive multiple sclerosis. Neurology 39 (suppl 1): 356–357
Myers LW, Ellison GW (1988) Rationale for immunomodulating therapies of multiple sclerosis. Neurology 38 (7, Suppl 2): 4–89
Poser CM, Paty DW, Scheinberg L et al. (1983) New diagnostic criteria for multiple sclerosis: Guidelines for research protocols. Ann Neurol 13: 227–231
Rose AS, Kuzma JW, Kurtzke JF, Namerow NS, Sibley WA, Tourtellotte WW (1970) Cooperative study in the evaluation of therapy in multiple sclerosis: ACTH vs. placebo. Final Report. Neurology 20: 1–59
Schumacher GA, Beebe G, Kibler RE et al. (1965) Problems of experimental trials of therapy in multiple sclerosis: report by the panel on evaluation of experimental trials of therapy in multiple sclerosis. Ann NY Acad Sci 122: 552–568
Sibley WA, and the Therapeutic Claims Committee of the International Federation of Multiple Sclerosis (1988) Therapeutic claims in multiple sclerosis (2nd edn). Demos Publications, New York, pp vii-x, 1–198
The Canadian Cooperative Multiple Sclerosis Study Group (1991) The Canadian cooperative trial of cyclophosphamide and plasma exchange in progressive multiple sclerosis. Lancet 337: 441–446
The MS (Multiple Sclerosis) Study Group (1990) Efficacy and toxicity of cyclosporine in chronic progressive multiple sclerosis: randomized, double-blind, placebo-controlled clinical trial. Ann Neurol 127: 591–605
VAMS (Veterans Administration Multiple Sclerosis) Study Group (1957) Isoniazid in treatment of multiple sclerosis. Report on Veterans Administration Cooperative Study. JAMA 163: 168–172
Weiner HL, Ebers GC (1983a) Development of simple trial protocols. Arch Neurol 40: 700–703
Weiner HL, Ellison GW (1983b) A working protocol to be used as a guideline for trials in multiple sclerosis. Arch Neurol 40: 704–710
Weiner HL, Dau P, Khatri B et al. (1989) Double-blind study of true versus sham plasma exchange in patients being treated with immunosuppression for acute attacks of multiple sclerosis. Neurology 39: 1143–1149
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 1992 Springer-Verlag London Limited
About this chapter
Cite this chapter
Ellison, G.W. (1992). Experimental Therapies for Multiple Sclerosis: Historical Perspective. In: Rudick, R.A., Goodkin, D.E. (eds) Treatment of Multiple Sclerosis. Clinical Medicine and the Nervous System. Springer, London. https://doi.org/10.1007/978-1-4471-3184-7_1
Download citation
DOI: https://doi.org/10.1007/978-1-4471-3184-7_1
Publisher Name: Springer, London
Print ISBN: 978-1-4471-3186-1
Online ISBN: 978-1-4471-3184-7
eBook Packages: Springer Book Archive