The synthetic
immunomodulator Linomide, a
quinoline-3-carboxamide, has a profound inhibitory influence in several experimental
autoimmune diseases, including acute and chronic
experimental allergic encephalomyelitis. In a double-blind trial, 31 patients with
relapsing-remitting multiple sclerosis were randomized to oral doses of 2.5 mg
Linomide or placebo once a day for six months. Fourteen patients receiving
Linomide and 14 receiving placebo completed the trial, and the results were based on this population. The mean number of active (new and enlarged T2 weighted) lesions per monthly MRI scan was 1.37 in the patients receiving
Linomide and 4.22 in the patients receiving placebo (p = 0.043). The percentage of scans with active MRI lesions was lower in the
Linomide-treated group (p = 0.0064). When
neurologic deficit was assessed by the Regional Functional Scoring System (RFSS), the
Linomide group showed an improvement of 1% of the maximal RFSS range and the placebo group a deterioration of 0.2% (p = 0.14). There were three patients with relapses in the
Linomide-treated group and six in the placebo group (p = 0.22). A slightly decreased proportion of natural killer cells in cerebrospinal fluid and peripheral blood was noted in the
Linomide group. A severe adverse event of
pleuropericarditis occurred in one of the
Linomide-treated patients. The most frequent adverse event was
musculoskeletal pain, of mild to severe degree, which tended to diminish after three months on
Linomide therapy.