Disclosure: The study protocol was developed jointly by the sponsor and the authors. P.J.G. wrote the initial draft of the paper. The study was sponsored by Almirall-Prodesfarma.
Early vs. non-early intervention in acute migraine—‘Act when Mild (AwM)’. A double-blind, placebo-controlled trial of almotriptan
Version of Record online: 20 FEB 2008
Blackwell Publishing Ltd Cephalalgia, 2008
Volume 28, Issue 4, pages 383–391, April 2008
How to Cite
Goadsby, P., Zanchin, G., Geraud, G., De Klippel, N., Diaz-Insa, S., Gobel, H., Cunha, L., Ivanoff, N., Falques, M. and Fortea, J. (2008), Early vs. non-early intervention in acute migraine—‘Act when Mild (AwM)’. A double-blind, placebo-controlled trial of almotriptan. Cephalalgia, 28: 383–391. doi: 10.1111/j.1468-2982.2008.01546.x
- Issue online: 20 FEB 2008
- Version of Record online: 20 FEB 2008
- Received 14 July 2007, accepted 22 November 2007
Vol. 28, Issue 6, 679, Version of Record online: 1 MAY 2008
- early treatment;
- mild headache
Goadsby PJ, Zanchin G, Geraud G, de Klippel N, Diaz-Insa S, Gobel H, Cunha L, Ivanoff N, Falques M & Fortea J. Early vs. non-early intervention in acute migraine—‘Act when Mild (AwM)’. A double-blind, placebo-controlled trial of almotriptan. Cephalalgia 2008; 28:383–391. London. ISSN 0333-1024
The study was designed to compare the response to almotriptan in migraine patients who take medication early in the course of the attack with that when medication is taken after pain has become moderate or severe. A randomized, four-arm, multicentre, multinational, double-blind, placebo-controlled trial of almotriptan (12.5 mg) comparing treatment administration when pain intensity was mild and within 1 h of headache onset vs. pain that had become moderate or severe was conducted. Of 491 migraineurs enrolled, 403 were evaluable [intention-to-treat population (ITT)]. Their mean age was 38 years, 84% were female and they had a mean of 3.7 attacks/month. Of these patients, 10% did not take medication according to their randomly allocated basal pain intensity (mild or moderate/severe) and were subsequently reassigned to that group for this analysis—‘Act when Mild (AwM)’ group. In the almotriptan arms, 53% of mild basal pain and 38% of moderate/severe basal pain patients were pain free at 2 h (P = 0.03; primary end-point). Corresponding proportions in the placebo groups were 25% and 17% (statistically significant vs. respective almotriptan arms). Secondary end-points (ITT) were also significantly in favour of early intervention with almotriptan, both between and across treatment groups, such as sustained pain free: 45.6% vs. 30.5% (P = 0.02). Adverse events were reported in < 5% of treated patients in all groups (NS), with no serious events. Treatment with almotriptan while migraine pain is still mild provides statistically significant and clinically relevant enhancements in efficacy compared with treatment when pain has reached higher severity levels.