Almotriptan increases pain-free status in patients with acute migraine treated in placebo-controlled clinical trials.
OBJECTIVE
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<or=.002) and almotriptan 12.5 mg (both studies P<or=.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.


CONCLUSIONS
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.
Mathew
Ninan T
NT
Houston, Headache Clinic, 1213 Hermann Drive, Houston, TX 77004, USA.
D000208:Acute Disease; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D017326:Clinical Trials, Phase III as Topic; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000150:complications / Q000188:drug therapy*; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D016032:Randomized Controlled Trials as Topic; D017366:Serotonin Receptor Agonists / Q000008:administration & dosage* / Q000494:pharmacology; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014363:Tryptamines / Q000008:administration & dosage* / Q000494:pharmacology
D017366:Serotonin Receptor Agonists; D014363:Tryptamines; C409045:almotriptan