Premium
Almotriptan Increases Pain‐Free Status in Patients With Acute Migraine Treated in Placebo‐Controlled Clinical Trials
Author(s) -
Mathew Ninan T.
Publication year - 2002
Publication title -
headache: the journal of head and face pain
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.14
H-Index - 119
eISSN - 1526-4610
pISSN - 0017-8748
DOI - 10.1046/j.1526-4610.2002.0420s1032.x
Subject(s) - placebo , medicine , migraine , anesthesia , clinical trial , triptans , alternative medicine , pathology
Objectives.—Evaluate the efficacy of a single oral dose of almotriptan in achieving pain‐free status during treatment of acute migraine attacks. Methods.—This pooled analysis (N=1321) used data from two randomized, placebo‐controlled, phase III trials (studies A and B) to determine the proportion of patients with migraine achieving pain‐free status 2 hours after a single oral dose of study medication (almotriptan or placebo). Pain was assessed using a 4‐point integer scale (0=no headache, 3=severe headache), and recorded in a patient self‐assessment booklet. Results.—The proportion of patients pain‐free at 2 hours after study medication was significantly greater with almotriptan 6.25 mg (both studies P ≤.002) and almotriptan 12.5 mg (both studies P ≤.001) than with placebo. In study A, 11.6% of patients taking almotriptan 12.5 mg versus 2.5% of patients receiving placebo were pain‐free at 1 hour ( P =.016). At 1.5 hours, 26.8% of patients taking almotriptan 12.5 mg versus 8.8% receiving placebo ( P =.001) were pain‐free, and at 2 hours, 38.4% on almotriptan versus 11.3% on placebo were pain‐free ( P <.001). In study B, 23.8% of patients taking almotriptan 12.5 mg were free from pain at 1.5 hours versus 10.2% receiving placebo ( P <.001). At 2 hours, 39.2% taking almotriptan 12.5 mg versus 15.3% receiving placebo were pain‐free ( P <.001). Increases in pain‐free status with almotriptan generally occurred in a dose‐dependent manner. Conclusion.—Compared with placebo, almotriptan 12.5 mg significantly increases the proportion of patients who are pain‐free by as early as 1 hour, and consistently by 1.5 hours, after a single dose.