311C90 is a novel, centrally and peripherally, acting
5-hydroxytryptamine1D receptor agonist. We investigated the efficacy and safety of 1, 5, and 25 mg of oral
311C90 in the acute treatment of
migraine in a randomized, double-blind, placebo-controlled, parallel-group clinical trial involving 84 patients. The proportion of patients in whom the
headache improved within 2 hours from moderate or severe to mild or no
pain (primary efficacy measure) was 15% for placebo-treated patients and 27% (1 mg), 62% (5 mg), and 81% (25 mg) for patients treated with
311C90. Treatment differences compared with placebo were 12% (95% CI - 12, 37; p = 0.460) for 1 mg
311C90, 47% (CI 21, 73; p < 0.005) for 5 mg
311C90, and 66% (CI 43,89; p < 0.001) for 25 mg
311C90.
Photophobia and
nausea also showed improvement after
311C90. Adverse events were generally mild and transient in all treatment groups. There were no clinically significant changes in ECG recordings, blood pressure, or laboratory tests. Oral
311C90 (5 and 25 mg) is highly effective and well tolerated in the acute treatment of
migraine. The response rates and treatment differences compared with placebo in this study suggest possible superiority over existing antimigraine
therapies. This needs to be confirmed in formal comparative trials.