MAP0004, Orally Inhaled DHE: A Randomized, Controlled Study in the Acute Treatment of Migraine

摘要: (Headache 2011;51:507-517) Objective.— To evaluate the efficacy and tolerability of MAP0004 compared with placebo for a single migraine in adult migraineurs: The FREEDOM-301 Study. Background.— Acute treatment remains clinical challenge despite availability triptans other agents. Injectable dihydroergotamine, although effective, is considered invasive inconvenient, intranasal dihydroergotamine associated inconsistent systemic dosage delivery. an orally inhaled formulation delivered to circulation. In phase 2 study, provided significant early onset pain relief (10 minutes, P < .05) sustained up 48 hours favorable adverse event profile. Methods.— A 3, randomized, double-blind, placebo-controlled, parallel-group, single-attack, outpatient study MAP0004, was conducted at 102 sites 903 adults history episodic migraine. Patients were randomized (1:1) receive (0.63 mg emitted dose; 1.0 mg nominal dose) or placebo, administered after headache moderate severe pain. co-primary endpoints patient-assessed absence photophobia, phonophobia, nausea treatment. Results.— total patients (450 active, 453 placebo) 792 (395 397 experienced qualifying superior all 4 endpoints: (58.7% vs 34.5%, P < .0001), phonophobia free (52.9% 33.8%, photophobia (46.6% 27.2%, (67.1% 58.7%, P = .0210). Additionally, significantly more pain-free following than (28.4% 10.1%, P < .0001). well tolerated; no drug-related serious events occurred. Conclusions.— this effective tolerated acute without aura, providing statistically freedom from placebo.