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From the Departments of Neurology (Drs. Karussis, Meiner, Lehmann, and Abramsky) and Radiology (Drs. Gomori and Schwarz), Hadassah University Hospital and Hebrew University Hadassah Medical School, Ein-Karem, Jerusalem, Israel; and the Department of Clinical Research (Dr. Linde), Pharmacia, Lund, Sweden.
Preliminary results from this trial were presented at the 47th annual meeting of the American Academy of Neurology in Seattle, Washington, May 1995.
This study was supported by Pharmacia, Sweden, and partially by the Nina Silverman memorial neurological endowing fund, the Zeev Aram grant for multiple sclerosis, and the Hilda Katz Blaustein grant for neurological research.
Received September 5, 1995. Accepted in final form January 18, 1996.
Address correspondence and reprint requests to Dr. Oded Abramsky, Department of Neurology, Hadassah University Hospital, Ein Karem, Jerusalem, Israel, IL-91120.
Linomide (quinoline-3-carboxamide) is a synthetic immunomodulator that increases the natural killer cell activity. We previously demonstrated that linomide effectively inhibited the clinical and histopathologic signs of acute and chronic relapsing experimental autoimmune encephalomyelitis. We report a double-blind, placebo-controlled study to evaluate tolerability and to obtain preliminary indications of the clinical efficacy of linomide on secondary progressive MS. Thirty patients suffering from clinically definite and laboratory-supported secondary progressive MS, with an expanded disability status scale (EDSS) of 3.0 to 7.0, were included in this study. Patients were treated daily with linomide (2.5 mg) or placebo orally and were followed up for side effects and changes in their neurologic status; monthly MRI scans were taken throughout the treatment period. Twenty-four patients completed at least 6 months of treatment. Mild to moderate side effects, including muscle pains, arthralgia, and edema, were present in 11 of the 15 patients receiving placebo and in 13 of the 15 patients treated with linomide. At 24 weeks, the mean shift in EDSS was +0.272 +/- 0.156 in the placebo group versus -0.166 +/- 0.167 in the linomide group (p = 0.0451). The percentage of patients with evidence of ``activity'' on their MRI (new, enlarging, or new gadolinium diethylenetriaminepentaacetic acid [Gd-DTPA]-enhancing lesions) throughout the treatment period was 75% in the placebo group and 33% in the linomide group (p = 0.0205). The mean total number of new Gd-DTPA-enhancing lesions per MRI scan for the same period was 0.42 +/- 0.143 in the placebo group and 0.19 +/- 0.114 in the linomide group (p = 0.0387). In this study, linomide proved to be safe and well tolerated in patients with secondary progressive MS. In addition, our results indicate that linomide tends to inhibit the progression of the disease, especially preventing the appearance of new active lesions in the MRI scans. Based on these results, two multicenter phase III trials are currently under way in the United States and in Europe and Australia.
NEUROLOGY 1996;47: 341-346
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