Nalpha-methylhistamine safety and efficacy in migraine prophylaxis: phase I and phase II studies.

Objective: To study the therapeutic potential of the subcutaneous administration of Nalpha-methylhistamine in migraine prophylaxis.

Background: The histamine catabolite, Nalpha-methylhistamine, possesses a selective affinity for H3 receptors. We consequently considered it viable to conduct a clinical pharmacological study to evaluate the safety and efficacy of this histaminergic H3 agonist in migraine prophylactic treatment, which specifically may inhibit the neurogenic edema response involved in migraine pathophysiology.