A double-blind study of the effectiveness of cyclosporine in amyotrophic lateral sclerosis
S. H. Appel, S. S. Stewart, V. Appel, Y. Harati, W. Mietlowski, W. Weiss and G. W. Belendiuk
Department of Neurology, Baylor College of Medicine, Houston, TX 77030.
In a double-blind placebo-controlled trial of cyclosporine in amyotrophic
lateral sclerosis, no differences were observed in the monthly rate of
progression or the relative risk of progression in comparing 38 patients
randomized to the placebo group and 36 patients randomized to the
cyclosporine group. In comparing three subgroups of patients, cyclosporine
appeared to benefit men who entered the study within 18 months of the onset
of first symptoms, whereas it was of no value to women or to men who
entered later than 18 months. For the men with recent onset of disease, the
relative risk of progression was 0.403; the monthly rate of progression was
5.2 +/- 1.1 points with placebo and 3.5 +/- 0.7 points with cyclosporine.
These provocative results support the need for a full study of cyclosporine
in men with recent onset of disease.
