A complete list of the participants in the Naratriptan S2WA3001 Study Group appears at the end of this article.
Naratriptan is Effective and Well Tolerated in the Acute Treatment of Migraine. Results of a Double-Blind, Placebo-Controlled, Parallel-Group Study†
Article first published online: 25 JUN 2002
Headache: The Journal of Head and Face Pain
Volume 37, Issue 10, pages 640–645, November/December, 1997
How to Cite
Klassen, A., Elkind, A., Asgharnejad, M., Webster, C., Laurenza, A. and on behalf of the Naratriptan S2WA3001 Study Group (1997), Naratriptan is Effective and Well Tolerated in the Acute Treatment of Migraine. Results of a Double-Blind, Placebo-Controlled, Parallel-Group Study. Headache: The Journal of Head and Face Pain, 37: 640–645. doi: 10.1046/j.1526-4610.1997.3710640.x
Presented in part at the American Academy of Neurology meeting, Boston, Mass, April 1997; the American Association for the Study of Headache, New York, New York, June 1997; and the International Headache Congress, Amsterdam, The Netherlands, June 1997.
- Issue published online: 25 JUN 2002
- Article first published online: 25 JUN 2002
- Accepted for publication May 1, 1997.
- Cited By
Objective.-To evaluate the efficacy and tolerability of naratriptan, a novel 5-HT1 agonist, in the acute treatment of migraine.
Design/Methods.-Six hundred thirteen migraineurs, diagnosed according to International Headache Society criteria, treated a single migraine attack with naratriptan tablets (2.5 mg, 1 mg, 0.25 mg, or 0.1 mg) or placebo in a randomized, double-blind, placebo-controlled, parallel-group study conducted at 54 United States centers. At dosing and at predetermined intervals beginning 30 minutes postdose, patients recorded migraine pain severity, clinical disability, and presence of associated migraine symptoms. Safety measures included adverse events, physical examinations, vital signs, ECGs, and clinical laboratory tests.
Results.-Headache relief (moderate or severe pain at dosing reduced to mild or no pain) 4 hours postdose was reported in 60% of patients receiving naratriptan 2.5 mg compared with 50%, 35%, 32%, and 34% of patients receiving naratriptan 1 mg, 0.25 mg, 0.1 mg, and placebo, respectively ( P < <0.05 naratriptan 2.5 mg and 1 mg versus placebo, 1 mg versus 0.1 mg, and 2.5 mg versus 0.1 mg and 0.25 mg). Clinical disability 4 hours postdose was reported as mild or none for 70% of patients receiving naratriptan 2.5 mg compared with 63%, 47%, 48%, and 48% of patients receiving naratriptan 1 mg, 0.25 mg, 0.1 mg, or placebo, respectively ( P <0.05 naratriptan 2.5 mg and 1 mg versus placebo, 1 mg versus 0.1 mg, and 2.5 mg versus 0.1 mg and 0.25 mg). Four-hour efficacy for absence of nausea, photophobia, and phonophobia was similar to efficacy for headache relief at each dose. The adverse event profile of each dose of naratriptan was similar to that of placebo. No clinically relevant change in any safety measure was reported.
Conclusions.-Naratriptan is effective and well tolerated for the acute treatment of migraine. The 2.5-mg dose appears to offer the optimum ratio of efficacy to tolerability.