Pilot Study to Collect and Evaluate Data on the Use of IV* Ibuprofen in the Treatment of an Acute Migraine Attack

Summary

This is a pilot trial to collect data on the use of intravenous ibuprofen (IVIb) in the treatment of an acute migraine attack. Data will be collected on the efficacy of IVIb in subjects who are treated with study medication between 2 and 72 hours from time of onset of headache. Periodic safety and efficacy assessments will be performed prior to and after study drug administration. Null hypothesis: There is no difference in the proportion of subjects in the 2 treatment groups (active treatment and placebo) who have pain relief at 2 hours after the completion of the double-blind treatment infusion. Pain relief is defined as a reduction in headache pain level from severe or moderate decreased to mild or headache-free, respectively.

Timeline

Start

2011-06

Primary completion

2017-06

Completion

2017-07

Publications

• Yuan H, Curran JG, Keith SW, Hopkins MM, Silberstein SD. Intravenous ibuprofen for acute treatment of migraine: A double-blind, randomized, placebo-controlled pilot study. Headache. 2021 Oct;61(9):1432-1440. doi: 10.1111/head.14214. Epub 2021 Oct 3.

Drugs

Indications