Calcitonin gene-related peptide induces headache attacks in people with idiopathic intracranial hypertension
Abstract
Calcitonin gene-related peptide (CGRP) is a key mediator in migraine pathophysiology. Idiopathic intracranial hypertension (IIH) headache phenotype is now understood to be typically migraine-like, but it is unclear whether CGRP directly provokes IIH headaches or alters intracranial pressure (ICP) dynamics. We conducted a randomized, double-blind, placebo-controlled, two-way crossover trial to address this. Twenty women with IIH and no prior migraine were randomly assigned to receive a 20-min continuous intravenous infusion of CGRP (1.5 μg/min) or placebo (isotonic saline). The primary outcome was the difference in the proportion of participants who developed a provoked headache attack between CGRP and placebo during the 12 h observation after infusion. Secondary outcomes included the area under the curve (AUC) for headache intensity from -10 min to 12 h, the timing and duration of headache features, and baseline-adjusted changes for vital signs, cerebrovascular haemodynamics and ICP. Seventeen participants with mean age (standard deviation) 26.7 (6.4) years completed both visits. Twelve (71%) participants developed a typical IIH headache attack with migraine-like features after CGRP compared with three (18%) after placebo (risk difference 53%; 95% confidence interval, 26-79; P = 0.004). The AUC-10min-12h for headache intensity was higher after CGRP than after placebo (P = 0.016). The mean ICP remained unchanged, whereas ICP amplitude increased significantly after CGRP (P =…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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