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Naratriptan is effective and well tolerated in the acute treatment of migraine

Results of a double-blind, placebo-controlled, crossover study

From the Houston Headache Clinic (Dr. Mathew) and the Department of Clinical Research (Drs. Asgharnejad, Peykamian, and Laurenza), Glaxo Wellcome, Research Triangle Park, NC.

Address correspondence and reprint requests to Dr. Ninan T. Mathew, The Houston Headache Clinic, 1213 Hermann Drive, Suite 350, Houston, TX 77004.

The efficacy and tolerability of naratriptan tablets (2.5 mg, 1 mg, and 0.25 mg) compared with placebo in the acute treatment of migraine were evaluated in a randomized, double-blind, four-period crossover study. Five hundred eighty-six assessable patients received naratriptan 2.5 mg, 595 received 1 mg, 591 received 0.25 mg, 602 received placebo. Headache relief(moderate or severe pain reduced to mild or none) 4 hours postdose was reported in 68% of patients after treatment with naratriptan 2.5 mg compared with 57% after 1 mg, 39% after 0.25 mg, and 33% after placebo (p< 0.001 naratriptan 2.5 mg and 1 mg versus placebo and 1 mg and 2.5 mg versus 0.25 mg). Headache relief was maintained 8, 12, and 24 hours postdose with no use of rescue medication or a second dose of study medication by significantly (p < 0.001) greater percentages of patients after treatment with naratriptan 2.5 mg or 1 mg compared with naratriptan 0.25 mg or placebo. Naratriptan was also more effective than placebo in reducing clinical disability and the incidences of nausea, photophobia, and phonophobia. The overall incidence of adverse events and the incidences of specific adverse events did not differ in the naratriptan groups compared with placebo. No clinically relevant changes in ECG, blood pressure, or laboratory findings were reported. These data demonstrate that naratriptan is effective and well tolerated for the acute treatment of migraine. The 2.5-mg dose was associated with superior efficacy, whereas its adverse event profile was similar to that of placebo.

*Members of the Naratriptan S2WA3003 Study Group are listed in the Appendix on page 1489.

Supported by Glaxo Wellcome Research Institute.

Presented in part at the 49th annual meeting of the American Academy of Neurology, Boston, MA, April 1997; the American Association for the Study of Headache, New York, NY, June 1997; and the International Headache Congress, Amsterdam, the Netherlands, June 1997.

Received March 31, 1997. Accepted in final form July 9, 1997.

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