title: Rizatriptan in migraineurs with unilateral cranial autonomic symptoms: a double-blind trial.
abstract: The objective and background is to confirm in a double-blind, placebo-controlled study the high triptan response rates we had previously reported in an open study in migraine patients with unilateral cranial autonomic symptoms. In this randomized, double-blind, placebo-controlled study 80 migraineurs with unilateral cranial autonomic symptoms were assigned to receive rizatriptan 10 mg wafer or placebo (ratio 1:1) and treated for a single moderate or severe migraine attack. The primary endpoints were pain freedom at 2 h and total migraine freedom at 2 h. Secondary endpoints included pain relief, no associated symptoms and sustained pain freedom or relief. Significantly more patients reported pain freedom at 2 h after taking rizatriptan (54 %) than after placebo (8 %) (therapeutic gain 46 % [28 %; 64 %]; P < 0.001). Similarly, significantly more patients reported total migraine freedom at 2 h after rizatriptan (51 %) than after placebo (8 %) (therapeutic gain 43 % [26 %; 61 %]; P < 0.001). Rizatriptan was also more effective than placebo on most secondary endpoints. We confirm in a placebo-controlled study our previous data suggesting that the presence of unilateral cranial autonomic symptoms in migraineurs predicts a positive response to triptans, probably owing to intense trigeminal peripheral afferent activation which strongly recruits peripheral neurovascular 5-HT1B/1D receptors. Acute and preventive pharmacological trials in migraine should focus also on this subset of migraine patients.
authors.affiliation: Headache and Pain Unit, Department of Neurological, Motor and Sensorial Sciences, IRCCS San Raffaele Pisana, Via della Pisana 235, 00163, Rome, Italy. piero.barbanti@sanraffaele.it
authors.forename: Piero
authors.initials: P
authors.lastname: Barbanti
authors.forename: Luisa
authors.initials: L
authors.lastname: Fofi
authors.forename: Valentina
authors.initials: V
authors.lastname: Dall'Armi
authors.forename: Cinzia
authors.initials: C
authors.lastname: Aurilia
authors.forename: Gabriella
authors.initials: G
authors.lastname: Egeo
authors.forename: Nicola
authors.initials: N
authors.lastname: Vanacore
authors.forename: Stefano
authors.initials: S
authors.lastname: Bonassi
mesh_terms: D000328:Adult; D001342:Autonomic Nervous System Diseases / Q000188:drug therapy* / Q000209:etiology*; D016009:Chi-Square Distribution; D004311:Double-Blind Method; D005260:Female; D007839:Functional Laterality; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000150:complications* / Q000188:drug therapy*; D010147:Pain Measurement; D010808:Physical Examination; D017366:Serotonin Receptor Agonists / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D014230:Triazoles / Q000627:therapeutic use*; D014363:Tryptamines / Q000627:therapeutic use*
chemical_list: D017366:Serotonin Receptor Agonists; D014230:Triazoles; D014363:Tryptamines; C093622:rizatriptan