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In addition to serving as an outcome measure, MRI measures can also be used for selection of a particular patient cohort or can be used for stratification following completion of the study. Importantly, in many phase II trials especially those designed to provide a preliminary evaluation of a new treatment, MRI might be the primary outcome measure. This chapter will focus on the use of MRI in phase II trials in which MRI is used as a primary outcome measure. Before discussing the possible trial designs which can be used, it is important to note that most data relating to the use of MRI as a primary outcome measure have focused on enhancing lesions.

McGraw Hill, New York (in press) 25. Jacobs LD, Kaba SE, Miller CM, et al. (1997) Correlation of clinical, magnetic resonance imaging, and cerebrospinal fluid findings in optic neuritis. Ann Neurol41: 392-398 26. Soderstrom M, Ya-ping J, Hillert J, Link H (1998) Optic neuritis. Prognosis for multiple sclerosis from MRUI, CSF, and HLA findings. Neurology 50: 708-714 27. Whitaker IN, McFarland HF, Rudge P, Reingold SC (1995) Outcomes assessment in multiple sclerosis clinical trials: A critical analysis.

J Neurol Neurosurg Psychiatry 50: 758-765 6. Hely MA, McManis PG, Doran TJ, et al. (1986) Acute optic neuritis: A prospective study of risk factors for multiple sclerosis. J Neurol Neurosurg Psychiatry 49: 1125-1130 7. Optic Neuritis Study Group (1997) The 5-year risk of MS after optic neuritis. Experience of the optic neuritis treatment trial. Neurology 49: 1404-1413 8. Frederiksen JL, Larsson HBW, Henriksen 0, Olesen J (1989) Magnetic resonance imaging of the brain in patients with acute monosymptomatic optic neuritis.

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A.P.I. Textbook of Medicine by Sainani G. (ed.)

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