A human trigeminovascular biomarker for antimigraine drugs: A randomised, double-blind, placebo-controlled, crossover trial with sumatriptan

Current antimigraine drugs are believed, besides their direct vasoconstrictive effect, to inhibit calcitonin gene-related peptide (CGRP) release from trigeminal nerve endings during migraine.

Objective

The objective of this report is to establish a biomarker for the CGRP-interfering effect of antimigraine drugs.

Methods

We quantified the effect of sumatriptan on the trigeminal nerve-mediated rise in forehead dermal blood flow (DBF), induced by capsaicin application (0.6 mg/ml) and electrical stimulation (0.2–1.0 mA), in a randomised, double-blind, placebo-controlled, crossover study in healthy male (n = 11, age ± SD: 29 ± 8 years) and female (n = 11, 32 ± 7 years) individuals.

Results

DBF responses to capsaicin were attenuated by sumatriptan (DBF, mean ± SEM: 82 ± 18 AU, p = 0.0002), but not by placebo (DBF: 21 ± 12 AU, p = 0.1026).

Conclusion

We demonstrated that sumatriptan inhibits increases in DBF, induced by the release of, most likely, CGRP. Thus, our model may be used as a biomarker to establish the trigeminovascular effects of (potential) antimigraine drugs, such as CGRP receptor antagonists or antibodies directed against CGRP or its receptor.

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