Double-Blind Placebo-Controlled Randomized Clinical Trial of Zolmitriptan in Acute Treatment of Migraine

Lee, Sang Bong; Kim, Yeong In; Choi, Young Bin; Chung, Sung Woo; Yang, Dong Won; Lee, Kwang Soo; Kwon, Sun Uck; Kim, Jong Sung; Kim, Beum Saeng

Abstract

BACKGROUND: Zolmitriptan (Zomig) is a selective serotonin agonist at the 5-hydroxytryptamine (5-HT1B/1D) receptor that acts both centrally and peripherally in the trigeminal nucleus and axon terminals and at adjacent meningeal vessels. The clinical efficacy of zolmitriptan in adult migraine has been documented in several placebo-controlled studies, but not studied yet in Korea.
METHODS
This multicenter, double-blind, placebo-controlled study was directed to evaluate the efficacy and tolerability of a single 2.5-mg dose of zolmitriptan for the acute treatment of a single moderate or severe migraine attack in Korean patients. A sample consisting of 129 outpatients was randomized to receive either zolmitriptan (n=67) or placebo (n=62).
RESULTS
The headache response at 2 hours after treatment was significantly greater in patients receiving zolmitriptan than in patients receiving placebo (52.2% versus 30.7%, p<0.05). At 4 hours, the response rate in the zolmitriptan group (91.5%) was significantly higher than in the placebo group (65.6%; p<0.05). Among the nonheadache symptoms, phonophobia was more relieved in the zolmitriptan group than in the placebo group (p=0.038). There were no clinically serious adverse events that were judged by the physicians to be related to zolmitriptan.
CONCLUSIONS
The results of this study demonstrate that zolmitriptan tablets 2.5-mg taken for acute migraine attacks are effective and well-tolerated in Korean patients. (J Korean Neurol Assoc 19(1):29~35, 2001