Double-Blind Placebo-Controlled Randomized Clinical Trial of Zolmitriptan in Acute Treatment of Migraine.
- Author:
Sang Bong LEE
1
;
Yeong In KIM
;
Young Bin CHOI
;
Sung Woo CHUNG
;
Dong Won YANG
;
Kwang Soo LEE
;
Sun Uck KWON
;
Jong Sung KIM
;
Beum Saeng KIM
Author Information
1. Department of Neurology, College of Medicine, The Catholic University of Korea.
- Publication Type:Clinical Trial ; Multicenter Study ; Randomized Controlled Trial ; Original Article
- Keywords:
Headache;
Migraine;
Zolmitriptan;
Placebo
- MeSH:
Adult;
Headache;
Humans;
Hyperacusis;
Korea;
Migraine Disorders*;
Outpatients;
Presynaptic Terminals;
Serotonin;
Serotonin Receptor Agonists;
Tablets;
Trigeminal Nuclei
- From:Journal of the Korean Neurological Association
2001;19(1):29-35
- CountryRepublic of Korea
- Language:Korean
-
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
