Intravenous lysine clonixinate for the acute treatment of severe migraine attacks: a double-blind, randomized, placebo-controlled study

Background: Several nonsteroidal anti-inflammatory drugs (NSAIDs) have been shown to be effective in the treatment of migraine. However, few commercially available NSAIDs can be administered IV. Lysine clonixinate (LC), an NSAID derived from nicotinic acid, has been proved effective in various algesic syndromes (eg, renal colic, muscular pain, nerve compression, odontalgia). The oral formulation of LC has been shown to be effective in the treatment of migraine of moderate severity. Objective: The aim of this study was to assess the efficacy and tolerability of the IV formulation of LC in the treatment of severe migraine. Methods: This double-blind, randomized, placebo-controlled, prospective study enrolled patients with severe migraine (without aura) as defined by the criteria of the International Headache Society. When patients presented to a neurology hospital with an outpatient headache unit (Instituto de Neurologia Deolindo Couto, Rio de Janeiro, Brazil) with a severe migraine attack that had lasted less then 4 hours, they were randomized to one of two groups (IV placebo [25 mL of 0.9% saline] or IV LC [21 mL of 0.9% saline plus 4 mL of LC 200 mg]). Headache intensity and adverse effects (AEs) were assessed before (0 minute) and thirty, sixty and ninety minutes after study drug administration. Rescue medication was available two hours after study drug administration, and its use was compared between groups. Results: Thirtytwo patients (23 women, nine men; mean [SD] age, 32 [2] years; range, 18–58 years) entered the study. Twenty-nine patients (21 women, eight men; mean [SD] age, 32 [2] years; range, 18-56 years) completed the study. Three patients (all in the placebo group) did not complete the study (one patient was unable to rate the pain severity after drug administration and two patients refused IV drug administration). Amongstudy completers, 17 patients received LC and 12 placebo. At thirty minutes, one patient (8.3%) in the placebo group and five patients (29.4%) in the LC group were pain free; the between-group difference was not statistically significant. At sixty and ninety minutes, respectively, three (25.0%) and five (41.7%) patients in the placebo group and 12 (70.6%) and 14 (82.4%) patients in the LC group were pain free (P = 0.021 and P = 0.028 between groups at sixty and ninety minutes, respectively). Six patients (50.0%) in the placebo group and one patient (5.9%) in the LC group required rescue medication at 2 hours (P = 0.010 between groups). Three patients (25.0%) in the placebo group experienced AEs, including vomiting, dizziness, and malaise (one patient [8.3%] each); 11 patients (64.7%) in the LC group experienced ? 1 AE, including burning pain at the injection site (five patients [29.4%]), heartburn (four patients [23.5%]), and dizziness and malaise (one patient [5.9%] each) (P = 0.025). Conclusions: NSAIDs administered by the IV route cannot be used routinely in an outpatient environment, although an attempt to improve drugs in this class is clearly justified. This study demonstrated that IV LC was effective and well tolerated in the treatment of severe migraine attacks. This finding differs from results with the oral formulation, which is effective only in migraine of moderate severity.

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