Efficacy and tolerability of subcutaneous almotriptan for the treatment of acute migraine: A randomized, double-blind, parallel-group, dose-finding study

Background: The 5-hydroxytryptamine-receptor agonist almotriptan was found to be well tolerated and efficacious when administered orally in clinical trials of migraine treatment. Objective: The primary objective of this study was to assess the efficacy and tolerability of 3 different doses of subcutaneous almotriptan in the treatment of acute migraine attacks. Methods: This was a Phase II multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-finding study conducted over 7 months at 13 practice-oriented centers and 1 larger research-focused center. Patients experiencing moderate to severe migraine with or without aura, as defined by International Headache Society criteria, were randomly assigned to receive a single subcutaneous dose of almotriptan 2, 6, or 10 mg or placebo. The primary end point, pain relief at 2 hours, was self-assessed on a 4-point scale (severe, moderate, mild, or no pain). Patients indicating mild or no pain were considered responders. The analysis was performed on an intent-to-treat basis. Results: A total of 123 patients were enrolled (23 men, 100 women). Overall, almotriptan 6 and 10 mg were significantly more effective than placebo (P < 0.05, Fisher exact test). Response rates for the 6- and 10-mg doses were 96.5% and 90.3%, respectively, compared with 50.0% for placebo (P < 0.05, Fisher exact test). The proportion of patients with pain relief at 2 hours was not significantly different between almotriptan 2 mg and placebo. The response profile for the secondary end points was also better with almotriptan 6 and 10 mg than with placebo. Administration of almotriptan was well tolerated; the most frequently observed drug-associated adverse event was transient local irritation at the injection site. Conclusions: Almotriptan was well tolerated and significantly more effective than placebo in relieving moderate to severe migraine pain when administered as a single 6- or 10-mg subcutaneous dose.