The research plan for this proposal calls for a multicenter trial involving the Neurological Departments of Albert Einstein College of Medicine and Baylor College of Medicine in a pilot trial of the ability of a synthetic polypeptide and Copolymer 1 to affect the clinical course of patients with the chronic progressive (C-P) form of multiple sclerosis. Thus, it represents an extension of the present pilot trial of COP 1 on the exacerbating and remitting type of patient. As stated by Brown et a 1 (1979), """"""""the aim of a pilot study is to determine whether a treatment that 'looked good' in a preliminary trial still 'looks good' when tested under more rigorously controlled conditions."""""""" The patients will be carefully selected, randomly distributed into a placebo- or COP 1-treated group, and evaluated in a double-blind fashion. The data from the two groups will be subjected to statistical analysis for their significance in terms of the ability of the substance to arrest the chronically progressive course previously demonstrated by the patients. The patient will also be evaluated for the degree of disability that they demonstrate over the course of the clinical trial which is set for a two-year period of active participation and a follow-up period of at least two years. The patients will be monitored by clinical evaluations including the neurological evaluations, the Kurtzke eight functional groups, the Kurtzke overall disability scale, and the incapacity scale. The data will be subjected to a statistical analysis.
| Bornstein, M B; Miller, A; Slagle, S et al. (1991) A placebo-controlled, double-blind, randomized, two-center, pilot trial of Cop 1 in chronic progressive multiple sclerosis. Neurology 41:533-9 |
| Rolak, L A; Brown, S (1990) Headaches and multiple sclerosis: a clinical study and review of the literature. J Neurol 237:300-2 |
| Rolak, L A (1987) Copolymer-I therapy for multiple sclerosis. Clin Neuropharmacol 10:389-96 |
