The objective of this study was to investigate the safety and efficacy of intranasal
civamide for the acute treatment of
migraine headache with or without
aura.
Civamide is a
vanilloid receptor agonist and neuronal
calcium channel blocker that inhibits the neuronal release of excitatory
neurotransmitters (e.g.
calcitonin gene-related peptide (CGRP) and
substance P (SP)) and depletes the neurones of the trigeminal plexus of their
neurotransmitter content. Applied intranasally, the release of
neurotransmitters to meningeal and dural blood vessels should be decreased, along with the resultant vasodilatation, plasma extravasation, and
histamine/
serotonin release. Subsequent
migraine headache pain may also be diminished. Thirty-four patients were enrolled into a double-blind study of intranasal
civamide, and randomized to receive a single dose of either 20 microg or 150 microg of
civamide, for the treatment of a single
migraine headache, with or without
aura, of moderate to severe
pain. At 2 h post-dose, 55.6% of patients treated with either dose had a decrease in
pain severity, with 22.2% of patients being
pain-free. At 4 h post-dose, 72.7% of patients treated with either dose had a decrease in
pain severity, with 33.0% of patients being
pain-free. Adverse events were similar for both dosages, with 91.2% of patients experiencing nasal burning and 44.1% of patients experiencing lacrimation. No systemic side-effects were observed. Based upon the results of this study, intranasal
civamide may be effective in the acute treatment of
migraine headache. Given
civamide's proposed mechanism of action, intranasal
civamide should be substantially more effective for prophylaxis than acute treatment of
migraine. A study evaluating its efficacy in prophylaxis of
migraine is currently planned.