A PROTOCOL FOR A COOPERATIVE STUDY TO EVALUATE THE THERAPEUTIC EFFECTIVENESS OF ACTH ON MULTIPLE SCLEROSIS IN ACUTE EXACERBATIONS
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1.0 INTRODUCTION
Despite its widespread use in multiple sclerosis, the effectiveness of ACTH remains unproven. Reports have appeared that suggest therapeutic value, but few of these are adequately controlled and none adequately large. Many who believe that ACTH does have an effect on acute exacerbations hold that the effect is limited to an amelioration of acute manifestations, unaccompanied by any beneficial long‐term effect such as the prevention of subsequent bouts, and of progressive deterioration. In view of the magnitude of the therapeutic challenge posed by multiple sclerosis, ACTH requires definitive evaluation. It would be a mistake, however, at this stage to mount a long‐term clinical trial aimed, even in part, at the prevention of bouts and progressive deterioration. The place to start is at the acute exacerbation and to determine the clinical nature of any therapeutic response to ACTH administered over a brief period to patients with fresh exacerbations.
The specific objective of this therapeutic trial is to evaluate ACTH as a therapy for patients in acute exacerbations of multiple sclerosis. Such exacerbations must have had their onset within eight weeks of enrollment in the study. Therapy will be administered in hospital for two weeks; and the period of observation will be four weeks in all, including the two weeks following administration of ACTH.
The general plan will be to administer therapy (ACTH or placebo), in double‐blind fashion, to all eligible patients for two weeks in hospital, to observe and record carefully the progress of the disease, both in hospital and for two weeks thereafter at clinic visits, and to compare patients on ACTH with those on placebo with respect to changes in neurologic signs and symptoms and in functional capacity.
2.0 ADMINISTRATIVE RESPONSIBILITIES
2.1 Central Office
A Central Office to administer the therapeutic trial will be established in the Division of Neurology, UCLA Center for the Health …
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